Status:
COMPLETED
Diabetes Dietary Study- Low Carbohydrate and Low-Fat Diets in Type 2 Diabetes
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
Robert C. Atkins Foundation
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
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 insul...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00795691
Start Date
May 1 2004
End Date
December 1 2008
Last Update
July 12 2019
Active Locations (1)
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1
Albert Einstein College of Medicine, General Clinical Research Center
The Bronx, New York, United States, 10461