Clinical trial NCT00795691: Diabetes Dietary Study- Low Carbohydrate and Low-Fat Diets in Type 2 Diabetes
Official title: High and Low Carbohydrate Weight Loss Approaches to Type 2 Diabetes Mellitus (The Diabetes Dietary Study (DDS))
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
low-carbohydrate diet
weight loss
obesity
dietary intervention
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Robert C. Atkins Foundation
First posted: 2008-11-21
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hemoglobin A1c at month 3
timeFrame: 3 months into treatment
measure: Hemoglobin A1c at month 6
timeFrame: 6 months into treatment
measure: Hemoglobin A1c at month 12
timeFrame: 12 months into treatment
measure: Change in Body Weight at month 3
timeFrame: Baseline and 3 months into treatment
measure: Change in Body Weight at month 6
timeFrame: Baseline and 6 months into treatment
measure: Change in Body Weight at month 12
timeFrame: Baseline and 12 months into treatment
Secondary outcomes:
measure: Change in Body Fat at month 6
timeFrame: Baseline and 6 months into treatment
measure: Change in Body Fat at month 12
timeFrame: Baseline and 12 months into treatment
measure: Change in Lean Body Mass at month 6
timeFrame: Baseline and 6 months into treatment
measure: Change in Lean Body Mass at month 12
timeFrame: Baseline and 12 months into treatment
measure: Change in antidiabetic medication dosage at month 3
timeFrame: Baseline and 3 months into treatment
measure: Change in antidiabetic medication dosage at month 6
timeFrame: Baseline and 6 months into treatment
measure: Change in antidiabetic medication dosage at month 12
timeFrame: Baseline and 12 months into treatment
measure: Change in insulin sensitivity at month 6
timeFrame: Baseline and 6 months into treatment
measure: Total Cholesterol at month 6
timeFrame: 6 months into treatment
measure: Total Cholesterol at month 12
timeFrame: 12 months into treatment
measure: High-density lipoprotein cholesterol at month 6
timeFrame: 6 months into treatment
measure: High-density lipoprotein cholesterol at month 12
timeFrame: 12 months into treatment
measure: Low-density lipoprotein cholesterol at month 6
timeFrame: 6 months into treatment
measure: Low-density lipoprotein cholesterol at month 12
timeFrame: 12 months into treatment
measure: Triglycerides at month 6
timeFrame: 6 months into treatment
measure: Triglycerides cholesterol at month 12
timeFrame: 12 months into treatment
measure: Dietary caloric intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
timeFrame: 6 months into treatment
measure: Dietary caloric intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
timeFrame: 12 months into treatment
measure: Dietary carbohydrate intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
timeFrame: 6 months into treatment
measure: Dietary carbohydrate intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
timeFrame: 12 months into treatment
measure: Dietary fat intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
timeFrame: 6 months into treatment
measure: Dietary fat intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
timeFrame: 12 months into treatment
measure: Dietary protein intake as assessed using the Dietary History Questionnaire (DHQ) at month 6
timeFrame: 6 months into treatment
measure: Dietary protein intake as assessed using the Dietary History Questionnaire (DHQ) at month 12
timeFrame: 12 months into treatment
measure: Physical activity was assessed by patient self-report at month 6
timeFrame: 6 months into treatment
measure: Physical activity was assessed by patient self-report at month 12
timeFrame: 12 months into treatment
measure: Quality of life as assessed using the Diabetes Quality of Life Scale at month 6
timeFrame: 6 months into treatment
measure: Quality of life as assessed using the Diabetes Quality of Life Scale at month 12
timeFrame: 12 months into treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine, General Clinical Research Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Judith Wylie-Rosett
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cunningham C, Johnson S, Cowell B, Soroudi N, Segal-Isaacson CJ, Davis NJ, Isasi CR, Wylie-Rosett J. Menu plans in a diabetes self-management weight loss program. J Nutr Educ Behav. 2006 Jul-Aug;38(4):264-6. doi: 10.1016/j.jneb.2006.01.013. No abstract available.
citation: Davis NJ, Cohen HW, Wylie-Rosett J, Stein D. Serum potassium changes with initiating low-carbohydrate compared to a low-fat weight loss diet in type 2 diabetes. South Med J. 2008 Jan;101(1):46-9. doi: 10.1097/SMJ.0b013e31815d2696.
citation: Davis NJ, Tomuta N, Schechter C, Isasi CR, Segal-Isaacson CJ, Stein D, Zonszein J, Wylie-Rosett J. Comparative study of the effects of a 1-year dietary intervention of a low-carbohydrate diet versus a low-fat diet on weight and glycemic control in type 2 diabetes. Diabetes Care. 2009 Jul;32(7):1147-52. doi: 10.2337/dc08-2108. Epub 2009 Apr 14.
citation: Davis NJ, Tomuta N, Isasi CR, Leung V, Wylie-Rosett J. Diabetes-specific quality of life after a low-carbohydrate and low-fat dietary intervention. Diabetes Educ. 2012 Mar-Apr;38(2):250-5. doi: 10.1177/0145721711436132. Epub 2012 Feb 7.
citation: Davis NJ, Crandall JP, Gajavelli S, Berman JW, Tomuta N, Wylie-Rosett J, Katz SD. Differential effects of low-carbohydrate and low-fat diets on inflammation and endothelial function in diabetes. J Diabetes Complications. 2011 Nov-Dec;25(6):371-6. doi: 10.1016/j.jdiacomp.2011.08.001. Epub 2011 Oct 27.