Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Dietary Supplement: conjugated linoleic acid (CLA)
- Registration Number
- NCT00607945
- Lead Sponsor
- Ohio State University
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0 g CLA Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant Avandia (Rosiglitazone) 4-8mg/day OR other diabetes medication currently prescribed to participant, 0 g CLA, 8 g Placebo oil (based on typical American diet) 3.2 g CLA Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 3.2 g CLA, 4.8 g placebo oil (based on typical American diet) 6.4 g CLA Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 6.4 g CLA, 1.6 g placebo oil (based on typical American diet) 6.4 g CLA conjugated linoleic acid (CLA) Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 6.4 g CLA, 1.6 g placebo oil (based on typical American diet) 3.2 g CLA conjugated linoleic acid (CLA) Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 3.2 g CLA, 4.8 g placebo oil (based on typical American diet)
- Primary Outcome Measures
Name Time Method Difference in change in body weight of the intervention groups Between baseline and week 32, or end of study
- Secondary Outcome Measures
Name Time Method Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin) Weeks -4, -1, 0, 8, 16, 24, 31, 32 BNP (brain type natriuretic peptide) Weeks -4 and 32 Change in lipid profile (TChol, LDL, HDL, C-reactive protein) Weeks -4, -1, 0, 8, 16, 24, 31, 32 Changes in liver enzymes (ALT and AST) Weeks -4, -1, 0, 8, 16, 24, 31, 32 Change in bone density, bone formation and resorption markers Weeks -4, -1, 31 Change in C-Peptide Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32 Change in fat mass Between baseline and week 32 Chronic stress (as measured by questionnaire) Weeks -4 and 32 Appetite (as measured by appetite rating scale) Weeks -4, 0, 16, 32 EKG Weeks -4, 16, 32 Energy balance (physical activity recalls, food records, indirect calorimetry) Weeks -1, 16, 31 Change in lean mass Between baseline and week 32 Change in insulin sensitivity Between week 0 and week 32 Edema Weeks -4, -1, 0, 8, 16, 24, 31, 32 Diabetes coping behaviors and self-efficacy Weeks -4, -1, 32 Change in glucose control Weeks -1, 16, 31 Compliance (fatty acid composition, pill counts) Weeks -1, 0, 8, 16, 24, 31, 32 Nutrition knowledge Weeks -4, 0, 32
Trial Locations
- Locations (1)
The Ohio State University Clinical Research Center (Davis Medical Research Center)
🇺🇸Columbus, Ohio, United States