Status:
COMPLETED
Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients
Lead Sponsor:
Boston Medical Center
Conditions:
Obesity
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I, 6 weeks: Intensive weight loss 42 obese subjects with type 2 diabetes mellitus or impaired fasting glucose (FBS greater than 100 mg/dl) and a patient at the Nutrition and Weight Management Ce...
Detailed Description
Phase I, 6 weeks: Intensive weight loss forty-two obese subjects with type 2 diabetes mellitus or impaired fasting glucose (FBS greater than 100 mg/dl) will be randomized to receive either an MCT-base...
Eligibility Criteria
Inclusion
- Patient of the Nutrition and Weight Management Center at Boston Medical Center
- Obese ( BMI equal or greater to 30 kg/m2
- Men and women
- Age more than or equal to 18 years
- Type 2 diabetes mellitus controlled by diet or use of Metformin or Impaired fasting glucose (FBS more than or equal to 100 mg/dl)
- Only diet-controlled diabetics or those on Metformin will be considered since all classes of anti-diabetic agents have different effects on appetite and body weight, which may confound the interpretation of study results.
Exclusion
- Currently not a patient at the Nutrition and Weight Management Center at Boston Medical Center
- Need for oral anti-diabetic agents (other than Metformin)
- Abnormal thyroid status: hyperthyroidism or hypothyroidism (TSH less than 0.5 or more than 5.0)
- Significant liver disease (bilirubin more than or equal to 2.0 or liver enzyme more than 3 times upper limited of normal range)
- Significant renal disease (creatinine more than or equal to 2.0)
- On the following medications known to affect carbohydrate and lipid metabolism: steroids, Beta adrenergic blockers, diuretics, insulin, and hypolipidemic agents
- Use of prescription or over the counter weight loss medications
- Weight loss of \>5% or more in the last three (3) months
- Anorexia nervosa or bulimia nervosa
- Pregnancy or lactation
- Significant lactose intolerance
- Significant egg allergy
- History of drug or alcohol addiction.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00207233
Start Date
July 1 2004
End Date
July 1 2009
Last Update
January 25 2011
Active Locations (1)
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1
Boston University Medical Center
Boston, Massachusetts, United States, 02118