Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00207233
• Date of registration: 14/09/2005
• Primary sponsor: Boston Medical Center
• Public title: Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients
• Scientific title: Use of MCT Oil for Enhancement of Weight Loss and Glycemic Control in Obese Diabetic Patients 2002-292G
• Date of first enrolment: July 2004
• Target sample size: 42
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00207233
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Caroline Apovian, MD
• Affiliation: Boston University

• Name: Diana Cullum-Dugan, RD.LD
• Affiliation: Boston University

• Name: Donald Hess, MD
• Affiliation: Boston University

• Name: James Kirkland, MD,PhD
• Affiliation: Boston University

• Name: Marie McDonnell, MD
• Affiliation: Boston University

• Name: Peter Burke, MD
• Affiliation: Boston University

• Name: Wen Guo, PhD
• Affiliation: Boston University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Obesity

Type 2 Diabetes Mellitus

Intervention(s)

Behavioral: LCT hypocaloric liquid diet

Behavioral: MCT oil hypocaloric liquid diet

Procedure: Subcutaneous abdominal adipose tissue biopsy

Primary Outcome(s)

Change in expression of selected adipocyte metabolic genes [Time Frame: 3 months]

Glycemic control [Time Frame: 3 months]

Waist circumference change [Time Frame: 3 months]

Weight change [Time Frame: 3 months]

Secondary ID(s)

H-22398

Source(s) of Monetary Support

Please refer to primary and secondary sponsors