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Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus - NCT00607945-43210(Clinical Trial 201447)



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City:  Columbus
State:  
OH
Zip Code: 43210
Conditions: Type 2 Diabetes Mellitus
Purpose: 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.
Study summary: 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 fat mass when administered concomitantly with oral diabetes medication, The rationale of this study is that using CLA to reduce body weight and body fat in people with T2DM may improve efficacy and longevity of the oral diabetes medications in the management of T2DM. We plan to test our central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims. Specific Aim 1: Determine the ability of CLA to reduce body weight and body fat mass in people using oral diabetes medication for management of T2DM. Specific Aim 2: Determine the ability of CLA to modulate insulin sensitivity when combined with oral diabetes medication. Specific Aim 3: Determine the safety and tolerability of CLA in combination with oral diabetes medication.
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
Study is available at: The Ohio State University Clinical Research Center (Davis Medical Research Center)
Columbus, OH 43210
United States

Primary Contact:
Julia R Richardson, MS, RD, LD
Email: richardson.429@osu.edu
Phone: 614-247-8235

Secondary Contact:
Rachel M Cole, MS, RD, LD
Email: cole.311@osu.edu
Phone: 614-247-8235
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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