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OBJECTIVE—To assess the effect of insulin resistance and the benefit of the fibrate, gemfibrozil, on the incidence of major cardiovascular events in subjects with low HDL cholesterol and a broad range of triglyceride values who participated in the Veterans Affairs High Density Lipoprotein Intervention Trial (VA-HIT). RESEARCH DESIGN AND METHODS—This intention-to-treat analysis, specified as a secondary objective in VA-HIT, determined using Cox proportional hazards models the 5-year combined incidence of nonfatal myocardial infarction, coronary heart disease (CHD) death, or stroke in relation to the presence or absence of insulin resistance (defined by the highest tertile of the homeostasis model assessment of insulin resistance, HOMA-IR) in conjunction with lower and higher levels of HDL cholesterol and triglycerides. The study population consisted of 2,283 men with known coronary heart disease (CHD), treated with either placebo or gemfibrozil, who could be subdivided into groups with diabetes with or without insulin resistance, with no diabetes but insulin resistance, and with neither diabetes nor insulin resistance. RESULTS—With insulin resistance there was a significantly higher relative risk (RR) of a cardiovascular event both with diabetes (RR of 1.62 with 95% CI of 1.28–2.06) and without diabetes (RR of 1.43 with 95% CI of 1.03–1.98) than without insulin resistance. Throughout both lower and higher ranges of HDL cholesterol and triglycerides, the rate of new cardiovascular events and the reduction of events with gemfibrozil was greater in subjects with insulin resistance than without, despite the finding that an increase in HDL cholesterol and a decrease in triglycerides with gemfibrozil was less with insulin resistance than without insulin resistance. CONCLUSIONS—Results show that in VA-HIT the occurrence of a new cardiovascular event and the benefit of fibrate therapy was much less dependent on levels of HDL cholesterol or triglycerides than on the presence or absence of insulin resistance.

OBJECTIVE—The purpose of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on body weight, glycemic control, and cardiovascular risk factors in metformin-treated type 2 diabetic patients. RESEARCH DESIGN AND METHODS—A 1-year multicenter, randomized, double-blind, placebo-controlled trial of 120 mg orlistat t.i.d. (n = 249) or placebo (n = 254) combined with a reduced-calorie diet was conducted in overweight and obese patients with suboptimal control of type 2 diabetes. RESULTS—After 1 year of treatment, mean (±SE) weight loss was greater in the orlistat than in the placebo group (−4.6 ± 0.3% vs. −1.7 ± 0.3% of baseline wt, P < 0.001). Orlistat treatment caused a greater improvement in glycemic control than placebo, as evidenced by a greater reduction in serum HbA1c, adjusted for changes in metformin and sulfonylurea therapy (−0.90 ± 0.08 vs. −0.61 ± 0.08, P = 0.014); a greater proportion of patients achieving decreases in HbA1c of ≥0.5 and ≥1.0% (both P < 0.01); and a greater reduction in fasting serum glucose (−2.0 ± 0.2 vs. −0.7 ± 0.2 mmol/l, P = 0.001). Compared with the placebo group, patients treated with orlistat also had greater decreases in total cholesterol, LDL cholesterol, and systolic blood pressure (all P < 0.05). Although more subjects treated with orlistat experienced gastrointestinal side effects than placebo (83 vs. 62%, P < 0.05), more subjects in the placebo group withdrew prematurely from the study than in the orlistat group (44 vs. 35%, P < 0.05). CONCLUSIONS—Orlistat is a useful adjunctive treatment for producing weight loss and improving glycemic control, serum lipid levels, and blood pressure in obese patients with type 2 diabetes who are being treated with metformin.

OBJECTIVE To determine whether implantable insulin pump (IIP) and multiple-dose insulin (MDI) therapy have different effects on cardiovascular risk factors in insulin-requiring patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A randomized clinical trial was conducted at seven Veterans Affairs medical centers in 121 male patients with type 2 diabetes between the ages of 40 and 69 years receiving at least one injection of insulin per day and with HbAlc levels of ≥8% at baseline. Weights, blood pressures, insulin use, and glucose monitoring data were obtained at each visit. Lipid levels were obtained at 0, 4, 8, and 12 months, and free and total insulin levels were obtained at 0, 6, and 12 months. All medications being taken were recorded at each visit. RESULTS No difference in absolute blood pressure, neither systolic nor diastolic, was seen between patients receiving MDI or IIP therapy, but significantly more MDI patients required antihypertensive medications. When blood pressure was modeled against weight and time, IIP therapy was significantly better than MDI therapy for systolic blood pressure in patients with BMI 34 kg/m2. Total cholesterol levels decreased in the overall sample, but IIP patients exhibited significantly higher levels than MDI patients. Triglyceride levels increased over time for both groups, with IIP patients having significantly higher levels than patients in the MDI group. BMI was a significant predictor of, and inversely proportional to, HDL cholesterol level. No difference in lipid-lowering drug therapy was seen between the two groups. Free insulin and insulin antibodies tended to decrease in the IIP group as compared with the MDI group. C-peptide levels decreased in both groups. CONCLUSIONS IIP therapy in insulinrequiring patients with type 2 diabetes has advantages over MDI therapy in decreasing the requirement for antihypertensive therapy and for decreasing total and free insulin and insulin antibodies. Both therapies reduce total cholesterol and C-peptide levels

To assess the effect of insulin resistance and the benefit of the fibrate, gemfibrozil, on the incidence of major cardiovascular events in subjects with low HDL cholesterol and a broad range of triglyceride values who participated in the Veterans Affairs High Density Lipoprotein Intervention Trial (VA-HIT).This intention-to-treat analysis, specified as a secondary objective in VA-HIT, determined using Cox proportional hazards models the 5-year combined incidence of nonfatal myocardial infarction, coronary heart disease (CHD) death, or stroke in relation to the presence or absence of insulin resistance (defined by the highest tertile of the homeostasis model assessment of insulin resistance, HOMA-IR) in conjunction with lower and higher levels of HDL cholesterol and triglycerides. The study population consisted of 2,283 men with known coronary heart disease (CHD), treated with either placebo or gemfibrozil, who could be subdivided into groups with diabetes with or without insulin resistance, with no diabetes but insulin resistance, and with neither diabetes nor insulin resistance.With insulin resistance there was a significantly higher relative risk (RR) of a cardiovascular event both with diabetes (RR of 1.62 with 95% CI of 1.28-2.06) and without diabetes (RR of 1.43 with 95% CI of 1.03-1.98) than without insulin resistance. Throughout both lower and higher ranges of HDL cholesterol and triglycerides, the rate of new cardiovascular events and the reduction of events with gemfibrozil was greater in subjects with insulin resistance than without, despite the finding that an increase in HDL cholesterol and a decrease in triglycerides with gemfibrozil was less with insulin resistance than without insulin resistance.Results show that in VA-HIT the occurrence of a new cardiovascular event and the benefit of fibrate therapy was much less dependent on levels of HDL cholesterol or triglycerides than on the presence or absence of insulin resistance.

OBJECTIVE This study was designed to determine if food-containing hypocaloric diets are as effective as liquid-supplement diets in promoting weight loss for obese individuals with non-insulin-dependent diabetes mellitus (NIDDM). RESEARCH DESIGN AND METHODS Forty NIDDM subjects with body mass indexes (BMIs) of 30–40 kg/m2 were randomized to one of two 800-kcal diets for 12 weeks. Group A received liquid supplement only, and group B received supplement plus an evening meal. Both groups received an intensive behavioral education program. RESULTS Weight loss and improvements in glycemic, blood lipid, and blood pressure parameters were similar for the two groups. Weight loss averaged 15.7 kg for the entire group. The need for insulin, anti-diabetes, and anti-hypertensive medication decreased significantly. No serious side effects were observed. CONCLUSIONS Both food-containing and supplement diets providing 800 kcal a day effectively promote weight loss for obese individuals with NIDDM.

Diabetes diets should aim at ensuring an ideal body weight with normoglycemia and normolipidemia. The consensus recommendations of various diabetes associations suggest that these goals are most likely to be achieved by diets high in complex carbohydrates and fiber and low in fat. A typical diabetes diet containing 55–60% energy as carbohydrate (at least 66% complex)

Information on the carbohydrate, protein, fat, kilocalorie, and plant fiber content of 152 common foods has been collated. These data are based on information currently available and will need to be modified and updated as more information emerges. These data are presented in six tables that follow the format of the commonly used Exchange Lists for Meal Planning for patients with diabetes mellitus.

Plant fibers have important influences on gastrointestinal physiology and the absorption of many nutrients. Certain fibers delay the absorption of carbohydrates and result in less postprandial hyperglycemia. Because the intake of plant fibers lowers plasma glucose concentrations and decreases glycosuria, high-fiber foods may be useful in the management of diabetes mellitus. Consumption of selected fibers and fiber-rich foods lowers serum cholesterol values and may lower triglyceride concentrations. Plant fiber intake may lead to mineral depletion or vitamin deficiency, but this has not been observed in several long-term studies. Further work is required to delineate the therapeutic utility of plant fibers in the diet of persons with diabetes and to assess the undesirable effects of fiber intake. In our opinion, persons with diabetes who are eating very low-fiber diets would benefit from an increase in plant fiber intake from whole grains, legumes, and vegetables.

With new diabetes diet guidelines recommending high carbohydrate intake, questions arise regarding acceptable intake of simple sugars. Whereas several short-term studies report flattened glycemic and insulin response to fructose consumption, some also report increased serum triglyceride levels. Few studies examine the effects of long-term fructose consumption. We evaluated the long-term safety of fructose consumption in 14 middle-aged men with diabetes. Subjects followed an ambulatory high-fiber high-carbohydrate control diet at home for 8 wk, entered the hospital for 5 days on this diet, and spent the next 7 days on a similar diet supplemented with 50–60 g fructose. They continued the fructose diet at home for 23 wk, then resumed a postcontrol diet for an additional 16 wk. In the hospital, glycemic control improved significantly on the fructose-supplemented diet compared with the hospital control diet. In the ambulatory setting, no significant differences in plasma glucose, glycohemoglobin, serum cholesterol, triglycerides, lactate, or urate occurred between precontrol, fructose, or postcontrol periods. Fasting serum lactate was higher by 0.5 meq/L during the ambulatory fructose period than during the precontrol period. Body weight also increased during the ambulatory fructose period due to higher calorie intake. Adherence to fructose consumption was excellent and improved adherence to carbohydrate and fat recommendations. If total calorie intake is controlled to promote desirable body weight, crystalline fructose used with a high-carbohydrate high-fiber low-fat diet appears to be safe and acceptable for diabetic individuals.

The protein, carbohydrate, fat, plant fiber, and kilocalorie values of 35 breakfast cereals and wheat bran are presented. The total plant fiber as well as the soluble plant fiber content of these cereals is included.

High-carbohydrate, high-fiber (HCF) diets have beneficial therapeutic effects for selected patients with diabetes mellitus. We have treated 10 patients with HCF diets on a metabolic ward and followed them for an average of 15 months while they were on maintenance diets at home-. The HCF diets containing 70 per cent of calories as carbohydrate were accompanied by significant reductions in requirements for insulin or sulfonylureas. Fasting plasma glucose, serum cholesterol, and triglyceride values were significantly lower on the HCF diet than on a 43 per cent carbohydrate diet. On the HCF diet, insulin therapy was discontinued for five patients and sulfonylurea therapy for three. After an average of 15 months on the maintenance diet containing 55 per cent to 60 per cent carbohydrate, seven patients were still managed without insulin or sulfonylureas. Average fasting plasma glucose values during maintenance diets at home were identical to values on the HCF diets in the hospital. On the maintenance diet, serum cholesterol values were similar to initial values but serum triglyceride values were significantly lower than values on the 43 per cent carbohydrate diet. These studies indicate that moderately highcarbohydrate, high-fiber diets can be successfully followed at home and that improvements in glucose metabolism achieved in the hospital can be sustained outside the hospital.