Status:
COMPLETED
Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
GlaxoSmithKline
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
30-70 years
Phase:
PHASE1
Brief 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 bo...
Detailed Description
The long term goal of this research is to develop effective complementary strategies to aid in the management of type 2 diabetes (T2DM). Our central hypothesis is that CLA reduces body weight and body...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00607945
Start Date
January 1 2008
End Date
May 1 2012
Last Update
October 29 2024
Active Locations (1)
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1
The Ohio State University Clinical Research Center (Davis Medical Research Center)
Columbus, Ohio, United States, 43210