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OBJECTIVE To evaluate changes in the prevalence of depressive symptoms, loneliness, and insomnia among older adults with type 2 diabetes from 2016 to 2020 and to assess risk factors for these conditions including demographics, multimorbidity, BMI, treatment group, and pre-coronavirus 2019 (COVID-19) measure scores. RESEARCH DESIGN AND METHODS This was a prospective, observational study of participants from the Look AHEAD (Action for Health in Diabetes) cohort study. Data were from two assessments before COVID-19 (visit 1: April 2016–June 2018 and visit 2: February 2018–February 2020) and one assessment during COVID-19 (visit 3: July–December 2020). Surveys were administered to assess depressive symptoms, loneliness, and insomnia. RESULTS The study included 2829 adults (63.2% female, 60.6% White, mean [SD] age 75.6 [6.0] years). The prevalence of mild or greater depressive symptoms did not change significantly between the two pre-pandemic visits (P = 0.88) but increased significantly from pre- to during COVID-19 (19.3% at V2 to 30.4% at V3; P < 0.001). Higher odds of mild or greater depressive symptoms at V3 were associated with being female (adjusted odds ratio [OR] 1.4 [95% CI 1.1–1.7]), identifying as non-Hispanic White (OR 1.4 [95% CI 1.1–1.7]), having obesity (OR 1.3 [95% CI 1.0–1.5]), and reporting mild or greater depressive symptoms at V1 (OR 4.0 [95% CI 2.9–5.4]), V2 (OR 4.4 [95% CI 3.2–5.9]), or both visits (OR 13.4 [95% CI 9.7–18.4]). The prevalence of loneliness increased from 12.3% at V1 to 22.1% at V3 (P < 0.001), while the prevalence of insomnia remained stable across visits at 31.5–33.3%. CONCLUSIONS The prevalence of mild or greater depressive symptoms in older adults with diabetes was more than 1.6 times higher during COVID-19 than before the pandemic.

Objective. Patients with type 2 diabetes are encouraged to lose weight, but excessive weight loss in older adults may be a marker of poor health and subsequent mortality. We examined weight changes during the post-intervention period of Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) and diabetes support and education (DSE; control) in individuals with overweight/obesity and type 2 diabetes and sought to identify predictors of excessive post-intervention weight loss and its association with mortality. Research Design and Methods. These secondary analyses compared post-intervention weight change (year-8 to final visit [median 16 years]) in ILI and DSE in 3999 Look AHEAD participants. Using empirically derived trajectory categories, we compared four subgroups: Weight Gainers (N= 307), Weight Stable (N=1561), Steady Losers (N=1731) and Steep Losers (N=380) on post-intervention mortality, demographic variables and health status at randomization and year-8. Results. Post-intervention weight change averaged -3.7 ±9.5%, with greater weight loss in DSE than ILI. The steep weight loss trajectory subgroup lost on average 17.7 + 6.6%.; 30% of Steep Losers died during post-intervention follow-up vs 10-18% in other trajectories (pBaseline - older; longer diabetes duration; higher BMI; greater multimorbidity; Intervention – randomization to control group; less weight loss in years 1-8; Year 8 - higher prevalence of frailty, multimorbidity and depressive symptoms; lower use of weight control strategies. Conclusion. Steep weight losses post-intervention were associated with increased risk of mortality. Older individuals with longer duration diabetes and multi-morbidity should be monitored for excessive, unintentional weight loss.

Background. Look AHEAD, a randomized trial comparing intensive lifestyle intervention (ILI) and diabetes support and education (DSE) (control) in 5145 individuals with overweight/obesity and type 2 diabetes, found no significant differences in all-cause or cardiovascular mortality or morbidity during 9.6 (median) years of intervention. Participants in ILI who lost ≥10% at 1 year had lower risk of composite cardiovascular outcomes relative to DSE. Objective: Since effects of ILI may take many years to emerge, we conducted intent-to-treat analyses comparing mortality in ILI over 16.7 years (9.6 year of intervention and then observation) to DSE. In a secondary exploratory analysis, we compared mortality by magnitude of weight loss in ILI relative to DSE. Methods. Primary outcome was all-cause mortality from randomization to 16.7 years. Other outcomes included cause-specific mortality, interactions by sub-groups (age, sex, race/ethnicity, CVD history) and an exploratory analysis by magnitude of weight loss in ILI vs DSE as reference. Analyses used proportional hazards regression and likelihood ratio. Results. The incidence of all-cause mortality did not differ significantly in ILI and DSE (549 and 589 participants respectively); HR = 0.91; 95% CI (0.81,1.02), p=0.11. There were no significant differences between treatments in cause-specific mortality or within prespecified subgroups. ILI participants who lost ≥10% at 1 year had a 21% reduced risk of mortality (HR=0.79, CI 0.67,0.94, p=0.007) relative to DSE. Conclusions. ILI focused on weight loss did not significantly affect mortality risk. However, ILI participants who lost ≥10% had reduced mortality relative to DSE.

Objective: To evaluate changes in the prevalence of depressive symptoms, loneliness, and insomnia among older adults with type 2 diabetes from 2016 to 2020, and to assess risk factors for these conditions including demographics, multimorbidity, body mass index, treatment group, and pre-COVID-19 measure scores. Research Design and Methods: This was a prospective, observational study of participants from the Look AHEAD cohort study. Data were from two assessments before COVID-19 (Visit 1 (V1): April 2016-June 2018 and Visit 2 (V2): February 2018-February 2020), and one assessment during COVID-19 (Visit 3 (V3): July-December 2020). Surveys were administered to assess depressive symptoms, loneliness, and insomnia. Results: The study included 2829 adults (63.2% female, 60.6% white, mean [SD] age 75.6 [6.0] years). The prevalence of mild or greater depressive symptoms did not change significantly between the two pre-pandemic visits (p=0.88) but increased significantly from pre- to during COVID-19 (19.3% at V2 to 30.4% at V3 (p Conclusions: The prevalence of mild or greater depressive symptoms in older adults with diabetes was more than 1.6 times higher during COVID-19 than before the pandemic.

Among patients with type 2 diabetes (T2D), racial/ethnic minorities and those of lower socioeconomic status (SES) have a higher burden of coronary artery disease, chronic kidney disease, and hypoglycemia. Therefore, these groups may especially benefit from newer diabetes medication classes (GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors), but high cost may limit access. We conducted a secondary analysis of the Look AHEAD (Action for Health in Diabetes) randomized trial to assess the associations of race/ethnicity and SES with newer diabetes medication use. Look AHEAD compared an intensive lifestyle intervention to diabetes support and education among U.S. adults with obesity and T2D enrolled from 2001-2004. Medications, all prescribed outside of the study, were ascertained yearly. We used Cox proportional hazards models to estimate the association between self-reported race/ethnicity and SES factors and time to initiation of any newer diabetes medication through October 2019, adjusted for time-varying HbA1c, BMI, and number/type of diabetes medications; and baseline study arm, demographics, and comorbidities; fully-adjusted results are presented. Of 4,892 participants, 64%, 16%, 13%, and 8% were white, black, Hispanic, and other race/ethnicities, respectively. Over a median follow-up of 8.3 years, 44% initiated a newer diabetes medication. Black race was associated with significantly lower initiation of newer medications compared to whites (HR 0.81; 95% CI 0.80-0.94); there was no difference by other race/ethnic group. Yearly family income was inversely associated with the outcome: HR 0.69 (95% CI 0.55-0.87) comparing the lowest vs. the highest income group. Education, employment, and health insurance were not significantly associated with the outcome. These findings provide evidence of racial and SES disparities in use of newer diabetes medications, independent of glycemic control, that may impede access to these drugs for the individuals who need them most. Disclosure A. Elhussein: None. M. Bancks: None. W.C. Knowler: None. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. E.M. Vaughan: None. N.M. Maruthur: Other Relationship; Self; Johns Hopkins HealthCare Solutions. J. Clark: None. S.J. Pilla: None. Funding National Institute of Diabetes and Digestive and Kidney Diseases (U01DK057149)

The health effects of weight loss in older individuals with diabetes is unclear, perhaps related to intentionality of the weight loss. Look AHEAD (LA) is a randomized trial comparing intensive lifestyle intervention for intentional weight loss with diabetes support and education (control) in 5145 individuals (age 45-76 at baseline) with overweight/obesity and type 2 diabetes. We examined the association of weight change trajectories post-intervention (i.e., yrs 8 to 16; M± SD percent weight change= -3.10% ±10.1), and concurrent risk of mortality by comparing weight gainers (N=226), maintainers (N=1459), modest losers (N=2206), and steep losers (N=415). Both weight loss groups were older, more likely to be in DSE, and lost less weight in yrs 1-8. In Cox proportional hazards regression models, adjusted for sex, race, baseline obesity, age, and treatment, mortality risk among the 4 weight change categories differed significantly (p10 lb over 2 most recent 6-month assessments intentionally, unintentionally, or through the combination (intentional + unintentional), relative to maintainers (no weight loss>10 lb). Adjusted analyses showed that the HR for mortality was significantly greater in both the unintentional (HR=3.26, 95%CI 2.35,5.01) and the combination (HR=2.63, 95%CI 1.28,5.39), but not different in the intentional weight loss group (HR=1.05, 95%CI 0.61,1.81) relative to maintainers. These data suggest that unintentional weight loss is associated with increased risk of mortality in older individuals with diabetes. Disclosure R.R. Wing: None. J. Clark: None. M. Espeland: Other Relationship; Self; Boehringer Ingelheim International GmbH, Ironwood Pharmaceuticals. J.O. Hill: Stock/Shareholder; Self; Gelesis, Shakabuku LLC. R.W. Jeffery: None. K.C. Johnson: None. W.C. Knowler: None. R.H. Neiberg: None. K. Olson: None. H.O. Steinberg: None. H. Wyatt: Research Support; Self; National Cattleman’s Association, Novo Nordisk Inc. Stock/Shareholder; Self; Shakabuku LLC. Other Relationship; Self; FoodMinds. Funding National Institutes of Health

Whether intentional weight loss reduces mortality in overweight/obese individuals with diabetes is unclear. Look AHEAD, a randomized trial of intensive lifestyle intervention (ILI) and diabetes support and education (DSE) (control) in 5145 individuals with overweight/obesity and type 2 diabetes, is ideal for examining this due to large sample, extended follow-up, excellent retention, and sustained difference in weight loss (y1: 8.6% ILI; 0.7% DSE; y10: 6.1% ILI; 3.9% DSE). After 10 years of intervention, participants had 6-month calls and biennial visits. The primary outcome for the current phase is all-cause mortality from randomization to 16 years. Data were analyzed with proportional hazards regression stratified by clinical site; significance was based on the likelihood ratio. All-cause mortality was 9% lower in ILI compared to DSE, not a statistically significant difference (Fig 1). Deaths by arm were: ILI 496/2570 and DSE 530/2575. Interactions of treatment with prespecified subgroups (sex, CVD history, age) were not significant. In post-hoc analyses, ILI participants who lost >10% at 1year had an 18% reduced risk (HR=.82, CI 0.68,0.97) and ILI participants who gained or lost Disclosure R.R. Wing: None. J. Clark: None. E.W. Gregg: None. S.B. Kritchevsky: None. C.E. Lewis: None. D.M. Reboussin: None. T.A. Wadden: Board Member; Self; Novo Nordisk Inc., Weight Watchers International, Inc. L.E. Wagenknecht: None. S.Z. Yanovski: None. Funding National Institutes of Health

Objective: Exaggerated post-prandial incretin and insulin responses are well-documented in post-bariatric surgery hypoglycemia (PBH) after Roux-en-Y gastric bypass (RYGB). However, less is known about PBH after sleeve gastrectomy (SG). Thus, we sought to compare meal-stimulated hormonal response in those with PBH after SG vs. RYGB. Methods: We enrolled 20 RYGB (7 with and 13 without PBH) and 23 SG (12 with and 11 without PBH) who underwent bariatric surgery at our institution. PBH was defined as a postprandial interstitial or plasma glucose Results: Participants (N=43) were on average 5 years since surgery, with mean age of 50 years, mean preoperative BMI of 48 kg/m2, 81% female, 61% Caucasian, 53% post SG. There were no differences in fasting glucose (p=0.38) or fasting insulin (p=0.34) across the 4 groups. Among those with PBH, the SG group showed a lower peak glucose (131.8 mg/dl, p Conclusion: Among those with PBH, the SG group showed less glycemic excursion and different hormonal profiles including lower insulin, GLP-1 and higher GIP responses to MTT compared to the RYGB group. Future studies are needed to better understand the differential contribution of insulin and non-insulin mediated mechanisms behind PBH after SG vs. RYGB. Disclosure C. Lee: Consultant; Self; XOMA Corporation. Research Support; Self; Eiger BioPharmaceuticals. T. Brown: None. M. Schweitzer: Consultant; Self; Ethicon, Inc. T. Magnuson: None. J. Clark: None. Funding National Institutes of Health

Objective: Hypoglycemia after bariatric surgery is an increasingly recognized metabolic complication. We sought to determine the sensitivity and specificity of a prior hypo-sx survey in detecting post-bariatric surgery hypoglycemia (PBSH) using a continuous glucose monitor (CGM). Methods: Among the patients who underwent bariatric surgery at our institution and completed the hypo-sx survey, we enrolled 13 Roux-en-Y gastric bypass (RYGB, 7 with and 6 without hypo-sx) and 19 sleeve gastrectomy (SG, 9 with and 10 without hypo-sx) patients. Patients wore the CGM (Dexcom, San Diego, CA) for 72-120 hours at home. Hypoglycemia was defined as postprandial interstitial glucose (IG) Results: A total of 19 patients (59%) had hypoglycemia (Table 1), with a mean low glucose of 46.8 mg/dl. Two patients reported hypo-sx. The prevalence of hypoglycemia did not differ by the type of surgery (69% vs. 53%) or the presence of hypo-sx by survey (63% vs. 56%). The survey had a specificity of 53.8% and sensitivity of 52.6% for measured PBSH. Conclusions: Asymptomatic postprandial hypoglycemia was common in post-bariatric patients regardless of surgery type. Assessments that focus on hypoglycemic symptoms may not adequately capture PBSH. Future studies should consider CGM to assess the true prevalence and impact of PBSH. Table 1. Baseline Characteristics and Results from continuous glucose monitoring on post-bariatric surgery patients who were categorized as with or without symptoms of hypoglycemia based on their survey responsesRYGB with Hypo-sx (N=7)RYGB without Hypo-sx (N=6)SG with Hypo-sx (N=9)SG without Hypo-sx (N=10)P ALLP RYGB vs SGP With vs Without Hypo-sxMean Age, years52.9 (5.1)52.0 (10.0)41.9 (11.3)44.8 (11.9)% Female67%56%89%82%% Caucasian71%67%33%60%Time since surgery (years)7.3 (3.2)4.8 (1.3)4.7 (0.7)4.2 (0.8)Percent Patients with Postprandial Hypoglycemia (N)71% (5)67% (4)56% (5)50% (5)Total Average IG (mg/dl, SD)97.0 (6.7)103.5 (12.5)93.0 (8.1)96.9 (6.4)0.3730.2270.228Average Minimum IG (mg/dl, SD)47.7 (10.9)45.8 (9.7)46.4 (5.6)47.0 (9.9)0.8570.7440.429Postprandial Minutes/day IG Disclosure C. Lee: None. T. Brown: Advisory Panel; Self; Merck & Co., Inc. M. Schweitzer: Consultant; Self; Ethicon US, LLC.. T. Magnuson: None. J. Clark: None.

Bariatric surgery leads to more rapid and greater weight loss (WL) compared to medical weight loss (MWL), but differences in body composition changes for these methods of WL remain unclear. Due to the known health risks associated with central adiposity, we sought to understand if changes in regional distribution of fat mass (FM) and lean mass (LM) differ by surgical vs. medical WL. This 1:1:1 randomized trial among 15 persons with type 2 diabetes and BMI 30-39.9 kg/m2 compared changes in body composition (measured by dual energy x-ray absorptiometry) at the time of 10% WL (or nine months after intervention) for patients receiving MWL, adjustable gastric banding (AGB), or Roux-en-Y gastric bypass (RYGB). We used non-parametric tests to evaluate differences across all arms and to compare AGB to RYGB. We present results for the 12 participants who received the study intervention and completed follow-up. All participants were women, and 75% were African American. Time to 10% weight loss was shorter for AGB and RYGB. Total FM losses were similar across arms. While differences across arms were not statistically significant, the AGB arm tended to have greater total LM and peripheral FM losses. In conclusion, at similar overall WL, AGB may lead to preferential loss of peripheral FM and total LM. The change in total FM and truncal FM were similar across all three groups. Larger studies are needed to confirm these findings. MWLAGBRYGBPALLPAGB vs. RYGBN444Age (Years, Mean)4654.351.5Mean BMI, Kg/m2Baseline37.135.535Final353231.6Weight, KgBaseline104.796.394.4Final98.286.985.4% Change-6.1-9.8-10.00.0381.0Time to 10% Weight Loss, months7.472.772.510.0380.77Body Composition OutcomesTotal Fat Mass, KgBaseline50.043.044.5Final45.537.738.9% Change-8.5-12.0-12.90.671.0Truncal Fat Mass, KgBaseline24.424.724.2Final21.722.020.4% Change-11.0-10.9-16.30.670. 77Peripheral Fat Mass, KgBaseline24.217.019.2Final22.614.417.3% Change-5.0-15.0-8.70.670.56Lean Mass, KgBaseline53.251.546.9Final50.444.943.3% Change-5.2-12.4-7.30.070.15Abbreviations: MWL: medical weight loss, AGB: adjustable gastric band, RYGB: Roux-en-Y gastric bypass, BMI: body mass indexPALL for comparison across groups using Kruskal-Wallis testPAGB vs RYGB represents comparison of AGB to RYGB group using Wilcoxon-Mann-Whitney test Disclosure S. Varma: None. T. Brown: Advisory Panel; Self; Merck & Co., Inc.. J. Clark: None. N. Maruthur: None. M. Schweitzer: Consultant; Self; Ethicon US, LLC.. T. Magnuson: None. C. Lee: None.

In Brief This article reports on an investigation of whether an intensive lifestyle intervention (ILI) would reduce gastrointestinal symptoms over 4 years of follow-up for participants in the Action for Health in Diabetes (Look AHEAD) trial compared to a diabetes support and education (DSE) group. Look AHEAD is a randomized, multicenter trial comparing overweight and obese adults with type 2 diabetes treated with ILI versus DSE. ILI, and weight loss in general, had beneficial effects on gastrointestinal (GI) symptoms, with some variability in the strength of the effect depending on the specific symptom and time course. Potential modifiers were analyzed, yet ILI retained an association with improvement in GI symptoms.

OBJECTIVE We aim to characterize the effects on total body fat and distribution of a 1-year intensive lifestyle intervention (ILI) for weight loss in overweight and obese adults with type 2 diabetes and to examine whether changes in adipose tissue (AT) depots were associated with changes in metabolic biomarkers. RESEARCH DESIGN AND METHODS Participants were 54 females and 38 males (age 57.8 ± 6.7 years [mean ± SD]; BMI 31.7 ± 3.5 kg/m2) enrolled in the Look AHEAD (Action for Health in Diabetes) trial randomized to ILI or diabetes support and education (DSE) from whom baseline and 1-year MRI measures of total AT (TAT) and regional (arm, trunk, leg) AT, including subcutaneous AT (SAT), visceral AT (VAT), and intermuscular AT (IMAT), were acquired. We tested whether mean changes in ILI and DSE were equal and, within groups, whether changes were different from zero. Regression models tested whether changes in AT compartments were associated with metabolic variable changes. RESULTS Body weight changed −0.52 ± 3.62 kg (P = 0.31) in DSE and −7.24 ± 5.40 kg (P < 0.0001) in ILI. Mean ILI changes were different from DSE (P < 0.001 for TAT, SAT, and IMAT and P < 0.01 for VAT in females). Within ILI, SAT and VAT decreased in males and females (P < 0.0001), but IMAT was unchanged (0.00 ± 0.54 kg; P = 0.99). In DSE, SAT and VAT did not change, but IMAT increased by 0.46 ± 0.55 kg (P < 0.001). Controlling for weight loss, reduction of specific AT depots was associated with improvement in metabolic biomarkers. CONCLUSIONS Weight loss of 7–10% from an ILI over 1 year reduced SAT and VAT and prevented an increase in IMAT. Reductions in AT depots were associated with improvements in biomarkers.

OBJECTIVE To assess the relative impact of an intensive lifestyle intervention (ILI) on use and costs of health care within the Look AHEAD trial. RESEARCH DESIGN AND METHODS A total of 5,121 overweight or obese adults with type 2 diabetes were randomly assigned to an ILI that promoted weight loss or to a comparison condition of diabetes support and education (DSE). Use and costs of health-care services were recorded across an average of 10 years. RESULTS ILI led to reductions in annual hospitalizations (11%, P = 0.004), hospital days (15%, P = 0.01), and number of medications (6%, P < 0.001), resulting in cost savings for hospitalization (10%, P = 0.04) and medication (7%, P < 0.001). ILI produced a mean relative per-person 10-year cost savings of $5,280 (95% CI 3,385–7,175); however, these were not evident among individuals with a history of cardiovascular disease. CONCLUSIONS Compared with DSE over 10 years, ILI participants had fewer hospitalizations, fewer medications, and lower health-care costs.

OBJECTIVE We performed a systematic review to identify which genetic variants predict response to diabetes medications. RESEARCH DESIGN AND METHODS We performed a search of electronic databases (PubMed, EMBASE, and Cochrane Database) and a manual search to identify original, longitudinal studies of the effect of diabetes medications on incident diabetes, HbA1c, fasting glucose, and postprandial glucose in prediabetes or type 2 diabetes by genetic variation. Two investigators reviewed titles, abstracts, and articles independently. Two investigators abstracted data sequentially and evaluated study quality independently. Quality evaluations were based on the Strengthening the Reporting of Genetic Association Studies guidelines and Human Genome Epidemiology Network guidance. RESULTS Of 7,279 citations, we included 34 articles (N = 10,407) evaluating metformin (n = 14), sulfonylureas (n = 4), repaglinide (n = 8), pioglitazone (n = 3), rosiglitazone (n = 4), and acarbose (n = 4). Studies were not standalone randomized controlled trials, and most evaluated patients with diabetes. Significant medication–gene interactions for glycemic outcomes included 1) metformin and the SLC22A1, SLC22A2, SLC47A1, PRKAB2, PRKAA2, PRKAA1, and STK11 loci; 2) sulfonylureas and the CYP2C9 and TCF7L2 loci; 3) repaglinide and the KCNJ11, SLC30A8, NEUROD1/BETA2, UCP2, and PAX4 loci; 4) pioglitazone and the PPARG2 and PTPRD loci; 5) rosiglitazone and the KCNQ1 and RBP4 loci; and 5) acarbose and the PPARA, HNF4A, LIPC, and PPARGC1A loci. Data were insufficient for meta-analysis. CONCLUSIONS We found evidence of pharmacogenetic interactions for metformin, sulfonylureas, repaglinide, thiazolidinediones, and acarbose consistent with their pharmacokinetics and pharmacodynamics. While high-quality controlled studies with prespecified analyses are still lacking, our results bring the promise of personalized medicine in diabetes one step closer to fruition.

OBJECTIVE Weight loss through lifestyle changes is recommended for nonalcoholic fatty liver disease (NAFLD). However, its efficacy in patients with type 2 diabetes is unproven. RESEARCH DESIGN AND METHODS Look AHEAD (Action for Health in Diabetes) is a 16-center clinical trial with 5,145 overweight or obese adults with type 2 diabetes, who were randomly assigned to an intensive lifestyle intervention (ILI) to induce a minimum weight loss of 7% or a control group who received diabetes support and education (DSE). In the Fatty Liver Ancillary Study, 96 participants completed proton magnetic resonance spectroscopy to quantify hepatic steatosis and tests to exclude other causes of liver disease at baseline and 12 months. We defined steatosis >5.5% as NAFLD. RESULTS Participants were 49% women and 68% white. The mean age was 61 years, mean BMI was 35 kg/m2, mean steatosis was 8.0%, and mean aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were 20.5 and 24.2 units/l, respectively. After 12 months, participants assigned to ILI (n = 46) lost more weight (−8.5 vs. −0.05%; P < 0.01) than those assigned to DSE and had a greater decline in steatosis (−50.8 vs. −22.8%; P = 0.04) and in A1C (−0.7 vs. −0.2%; P = 0.04). There were no significant 12-month changes in AST or ALT levels. At 12 months, 26% of DSE participants and 3% (1 of 31) of ILI participants without NAFLD at baseline developed NAFLD (P < 0.05). CONCLUSIONS A 12-month intensive lifestyle intervention in patients with type 2 diabetes reduces steatosis and incident NAFLD.

OBJECTIVE—Intentional weight loss is recommended for those with type 2 diabetes, but the strategies patients attempt and their effectiveness for weight management are unknown. In this investigation we describe intentional weight loss strategies used and those related to BMI in a diverse sample of overweight participants with type 2 diabetes at enrollment in the Look AHEAD (Action for Health in Diabetes) clinical trial. RESEARCH DESIGN AND METHODS—This was a cross-sectional study of baseline weight loss strategies, including self-weighing frequency, eating patterns, and weight control practices, reported in 3,063 women and 2,082 men aged 45–74 years with BMI ≥25 kg/m2. RESULTS—Less than half (41.4%) of participants self-weighed ≥1/week. Participants ate breakfast 6.0 ± 1.8 days/week, ate 5.0 ± 3.1 meals/snacks per day, and ate 1.9 ± 2.7 fast food meals/week. The three most common weight control practices (increasing fruits and vegetables, cutting out sweets, and eating less high-carbohydrate foods) were reported by ∼60% of participants for ≥20 weeks over the previous year. Adjusted models showed that self-weighing less than once per week (B = 0.83), more fast food meals consumed per week (B = 0.14), and fewer breakfast meals consumed per week (B = −0.19) were associated (P < 0.05) with a higher BMI (R2 = 0.24). CONCLUSIONS—Regular self-weighing and breakfast consumption, along with infrequent consumption of fast food, were related to lower BMI in the Look AHEAD study population.

OBJECTIVE—The effectiveness of intentional weight loss in reducing cardiovascular disease (CVD) events in type 2 diabetes is unknown. This report describes 1-year changes in CVD risk factors in a trial designed to examine the long-term effects of an intensive lifestyle intervention on the incidence of major CVD events. RESEARCH DESIGN AND METHODS—This study consisted of a multicentered, randomized, controlled trial of 5,145 individuals with type 2 diabetes, aged 45–74 years, with BMI >25 kg/m2 (>27 kg/m2 if taking insulin). An intensive lifestyle intervention (ILI) involving group and individual meetings to achieve and maintain weight loss through decreased caloric intake and increased physical activity was compared with a diabetes support and education (DSE) condition. RESULTS—Participants assigned to ILI lost an average 8.6% of their initial weight vs. 0.7% in DSE group (P < 0.001). Mean fitness increased in ILI by 20.9 vs. 5.8% in DSE (P < 0.001). A greater proportion of ILI participants had reductions in diabetes, hypertension, and lipid-lowering medicines. Mean A1C dropped from 7.3 to 6.6% in ILI (P < 0.001) vs. from 7.3 to 7.2% in DSE. Systolic and diastolic pressure, triglycerides, HDL cholesterol, and urine albumin-to-creatinine ratio improved significantly more in ILI than DSE participants (all P < 0.01). CONCLUSIONS—At 1 year, ILI resulted in clinically significant weight loss in people with type 2 diabetes. This was associated with improved diabetes control and CVD risk factors and reduced medicine use in ILI versus DSE. Continued intervention and follow-up will determine whether these changes are maintained and will reduce CVD risk.

OBJECTIVE To characterize the association of low HbA1c values ( RESEARCH DESIGN AND METHODS Cross-sectional study of 12,533 participants without diabetes aged RESULTS HbA1c values ranged from 3.2 to 15.7%, and 84 participants had HbA1c CONCLUSIONS Low HbA1c values were associated with liver enzymes and steatosis in the U.S. population. Liver disease may partially explain the association of HbA1c with mortality and other long-term outcomes.