High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus (The Diabetes Dietary Study (DDS))
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c at month 3
研究概览
简要总结
The purpose of this study is to determine the effects of a low-carbohydrate diet compared to a low-fat/high-carbohydrate diet on glucose control in patients who have Type 2 Diabetes.
详细描述
Obesity is not only a risk factor for type 2 diabetes but it also frequently increases the need for insulin requirement in people with type 2 diabetes who are overweight or obese. However, since insulin is a lipogenic hormone, insulin or sulfonylurea therapy that increases circulating insulin levels often results in additional weight gain. Controlled-carbohydrate "ketogenic" diets have been popular as an alternative way of losing weight, but little is known about the safety and efficacy of using a ketogenic approach in the management of overweight/obese patients with type 2 diabetes.
The proposed study will randomize a group of 126 overweight or obese (BMI > 25 and < 40) adults with type 2 diabetes to either a low-carbohydrate or a low-fat weight loss diet. The primary study endpoint will be six and twelve month changes in glycemic control as measured by hemoglobin A1c (HbA1c). Secondary endpoints include adiposity (BMI, body composition and fat distribution); blood glucose patterns (from self-monitoring records); change in antidiabetic medications (potential decrease in number and dosage), lipids, insulin sensitivity from a meal tolerance test, other metabolic markers (C-reactive protein, leptin) and participants' lifestyle (physical activity and diet) and perceptions of satiety, quality of life, mood, and well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of type 2 diabetes
- •HbA1c 7-10%
- •BMI (kg/m2) > 25 and < 40 and weight < 280 lb.
- •Skill at and willingness to perform capillary blood glucose self-monitoring ---Insulin (changed to long-acting basal during run-in) or sulfonylurea treatment
排除标准
- •Age > 65
- •Weight >280 lb
- •Health conditions that may interfere with study participation or for which the study interventions may be contraindicated. These include: kidney stones or kidney disease (creatinine > 1.3 and 1.5 mg/dL for females and males, respectively; proteinuria > 300 ug/g creatinine); liver or gall bladder disease; significant heart disease (myocardial infarction in the past six months, prior or current evidence of congestive heart failure, other evidence of left ventricular (LV) dysfunction) or other indices of active cardiac abnormalities, (angina, electrocardiogram evidence of ischemia or transmural myocardial infarction), significant anemia; and cancer (other than effectively treated non melanomatous skin cancer and surgically treated cervical cancer in situ).
- •Current hypokalemia defined as serum potassium levels <3.5 mg/dL.
- •Osteoporosis
- •Type 1 diabetes (history of ketoacidosis or undetectable fasting C-peptide levels)
- •History of severe or repeated hypoglycemia, or hypoglycemia unawareness. Lack of recourse to another person in the immediate vicinity in the unlikely event that they require outside assistance for severe hypoglycemia.
- •Triglyceride levels > 400 mg/dL.
- •Inability or unwillingness to comply with any aspects of the dietary and research protocol.
- •Weight changes > 10 lbs in the past three months.
- •History of binge eating disorder or other eating disorders.
- •Pregnancy or intention to become pregnant in the next 12 months.
- •Current oral hypoglycemic medication that raises the blood insulin level
研究组 & 干预措施
Low-carbohydrate diet
The low-carbohydrate diet was based on the Atkins weight loss diet. The daily intake goals were to restrict intake of carbohydrate to 20-25 grams for the first 2-week phase. If body weight decreased, the daily goal for carbohydrate was increased by 5 grams. If body weight increased, the daily goal for carbohydrate intake was decreased by 5 grams. The minimum goal for carbohydrate intake was 20 grams per day and the maximum goal was 50 grams per day.
干预措施: low-carbohydrate diet (Behavioral)
Low-fat diet
The low-fat diet was based on the algorithm used to restrict fat and calorie intake in the Diabetes Prevention Program. The daily goals for fat intake was based on an algorithm to reduce total calorie intake to achieve a one pound weight loss per week with 25% of calories from fat.
干预措施: low-fat diet (Behavioral)
结局指标
主要结局
Hemoglobin A1c at month 3
时间窗: 3 months into treatment
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Hemoglobin A1c at month 6
时间窗: 6 months into treatment
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Hemoglobin A1c at month 12
时间窗: 12 months into treatment
Hemoglobin A1c (HbA1c) is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. HbA1c level indicates blood glucose levels over the previous 2 - 3 months. HbA1c values between 4 and 5.6 are considered normal. HbA1c values greater than 6.5 indicate diabetes.
Change in Body Weight at month 3
时间窗: Baseline and 3 months into treatment
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
Change in Body Weight at month 6
时间窗: Baseline and 6 months into treatment
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
Change in Body Weight at month 12
时间窗: Baseline and 12 months into treatment
Change in body weight often reflects the effects of dietary changes. Generally, an increase in body weight is correlated with increasing blood glucose levels while a decrease in body weight correlates to decreasing blood glucose levels. Dietary changes that result in decreased body weight will be associated with better glucose control.
次要结局
- Change in Lean Body Mass at month 12(Baseline and 12 months into treatment)
- Change in insulin sensitivity at month 6(Baseline and 6 months into treatment)
- Low-density lipoprotein cholesterol at month 6(6 months into treatment)
- Change in Body Fat at month 6(Baseline and 6 months into treatment)
- Change in antidiabetic medication dosage at month 3(Baseline and 3 months into treatment)
- Dietary protein intake as assessed using the Dietary History Questionnaire (DHQ) at month 12(12 months into treatment)
- Change in Body Fat at month 12(Baseline and 12 months into treatment)
- Change in Lean Body Mass at month 6(Baseline and 6 months into treatment)
- Change in antidiabetic medication dosage at month 6(Baseline and 6 months into treatment)
- Change in antidiabetic medication dosage at month 12(Baseline and 12 months into treatment)
- Total Cholesterol at month 6(6 months into treatment)
- High-density lipoprotein cholesterol at month 6(6 months into treatment)
- Low-density lipoprotein cholesterol at month 12(12 months into treatment)
- Triglycerides at month 6(6 months into treatment)
- Triglycerides cholesterol at month 12(12 months into treatment)
- Total Cholesterol at month 12(12 months into treatment)
- High-density lipoprotein cholesterol at month 12(12 months into treatment)
- Dietary carbohydrate intake as assessed using the Dietary History Questionnaire (DHQ) at month 12(12 months into treatment)
- Dietary fat intake as assessed using the Dietary History Questionnaire (DHQ) at month 6(6 months into treatment)
- Dietary caloric intake as assessed using the Dietary History Questionnaire (DHQ) at month 6(6 months into treatment)
- Dietary carbohydrate intake as assessed using the Dietary History Questionnaire (DHQ) at month 6(6 months into treatment)
- Dietary fat intake as assessed using the Dietary History Questionnaire (DHQ) at month 12(12 months into treatment)
- Physical activity was assessed by patient self-report at month 6(6 months into treatment)
- Physical activity was assessed by patient self-report at month 12(12 months into treatment)
- Dietary caloric intake as assessed using the Dietary History Questionnaire (DHQ) at month 12(12 months into treatment)
- Dietary protein intake as assessed using the Dietary History Questionnaire (DHQ) at month 6(6 months into treatment)
- Quality of life as assessed using the Diabetes Quality of Life Scale at month 6(6 months into treatment)
- Quality of life as assessed using the Diabetes Quality of Life Scale at month 12(12 months into treatment)
研究者
Judith Wylie-Rosett
Professor, Department of Epidemiology and Population Health
Albert Einstein College of Medicine