Overview

Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA, might be useful in combination with diabetes medication. Some studies show that CLA can modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce body weight and body fat without interfering with the diabetes medications' effects on blood sugar.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ohio State University
Collaborators:
Bunge Loders Croklaan
GlaxoSmithKline
LifeScan
Loders Croklaan
National Center for Complementary and Integrative Health (NCCIH)
Treatments:
Rosiglitazone
Criteria
Inclusion Criteria:

- Diagnosis of type 2 diabetes mellitus

- HbA1c ≤ 9%

- Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 45 kg/m2)

- Age ≥ 30 and ≤ 70 years (postmenopausal if female)

- Stable medical therapy for past 3 months

- Stable body weight (within ± 2 kg) for past 3 months

- Plans to remain in the Columbus, OH metropolitan area for at least 1 year

Exclusion Criteria:

- Substance abuse

- Current use of prescription or over-the-counter medications or supplements known to
affect body composition

- Current use of prescription or over-the-counter medications or supplements known to
interact with thiazolidinediones(TZDs)

- Current or previous diagnosis of congestive heart failure

- Self-report of claustrophobia

- Abnormal liver function

- Impaired cognitive function

- Current or previous diagnosis of renal disease

- Gastrointestinal diseases or disorders

- Current use of hormone therapies, or use within the past 3 months

- Discontinuation of diabetes medication