Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant
* Dietary Supplement: conjugated linoleic acid (CLA)
* Dietary Supplement: conjugated linoleic acid (CLA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0 g CLA<br>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) | Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant<br>* Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32<br>* Other names: Avandia;|
| Experimental: 3.2 g CLA<br>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) | Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant<br>* Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32<br>* Other names: Avandia;Dietary Supplement: conjugated linoleic acid (CLA)<br>* 3.2 g/day, capsule, week 0 to week 32<br>* Other names: Tonalin, Clarinol;|
| Experimental: 6.4 g CLA<br>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) | Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant<br>* Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32<br>* Other names: Avandia;Dietary Supplement: conjugated linoleic acid (CLA)<br>* 6.4 g/day, capsule, week 0 to week 32<br>* Other names: Tonalin, Clarinol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in change in body weight of the intervention groups |  | Between baseline and week 32, or end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fat mass |  | Between baseline and week 32 | 
| Change in lean mass |  | Between baseline and week 32 | 
| Change in insulin sensitivity |  | Between week 0 and week 32 | 
| Change in lipid profile (TChol, LDL, HDL, C-reactive protein) |  | Weeks -4, -1, 0, 8, 16, 24, 31, 32 | 
| Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin) |  | 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 | 
| Edema |  | Weeks -4, -1, 0, 8, 16, 24, 31, 32 | 
| Change in glucose control |  | Weeks -1, 16, 31 | 
| 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 | 
| Diabetes coping behaviors and self-efficacy |  | Weeks -4, -1, 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 | 
| BNP (brain type natriuretic peptide) |  | Weeks -4 and 32 | 
| Energy balance (physical activity recalls, food records, indirect calorimetry) |  | Weeks -1, 16, 31 | 
| Compliance (fatty acid composition, pill counts) |  | Weeks -1, 0, 8, 16, 24, 31, 32 | 
| Nutrition knowledge |  | Weeks -4, 0, 32 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, conjugated linoleic acid, weight loss, rosiglitazone, glucose control, insulin sensitivity