Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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Conjugated linoleic acids (CLAs) comprise a family of linoleic acid (18:2n-6; LA) isomers that are formed by biohydrogenation and oxidation processes in nature. The main form of CLA, cis-9, trans-11-18:2, can be produced directly by bacterial hydrogenation in the rumen or by delta-9 desaturation of the co-product vaccenic acid (trans-11-18:1) in most mammalian tissues including man. The second most abundant isomer of CLA is the trans-10, cis-12-18:2 form. Observations clearly emphasize that differences exist between mammalian species in their response to CLAs with mice being the most sensitive. The majority of studies on body compositional effects (i.e. fat loss, lean gain), on cancer and cardiovascular disease attenuation, on insulin sensitivity and diabetes and on immune function have been conducted with a variety of animal models. Recent studies indicate that some but not all of the effects observed in animals also pertain to human volunteers. Reports of detrimental effects of CLA intake appear to be largely in mice and due mainly to the trans-10, cis-12 isomer. Suggestions of possible deleterious effects in man due to an increase in oxidative lipid products (isoprostanes) with trans-10, cis-12 CLA ingestion require substantiation. Unresponsiveness to antioxidants of these non-enzymatic oxidation products casts some doubt on their physiological relevance. We hypothesized that supplementation with CLA + an antioxidant (vitamin E) in patients with diabetes mellitus may have beneficial effects on glycemic control and insulin sensitivity.

Official Title
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Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E on Insulin Sensitivity, Beta Cell Function, Markers of Inflammation, Body Fat Mass and Other Biochemical Indicators in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Dietary Supplement: Tonalin SG1000T FFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of type 2 diabetes mellitus > 5 years HbA1c ≤ 9% Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 30 kg/m2) Age ≥ 30 and ≤ 70 years (postmenopausal if female) Stable medical therapy for past 3 months Stable serum glucose for past 3 months (128-180 mg/Dl) Age between 30 to 50 Use of metformin TG < 240 mg/Dl No alcohol, no insulin, no smoke No pregnancy, no menopause Exclusion Criteria: Personal history of coronary heart disease Cerebrovascular disease or vascular disease Renal or hepatic disease Inflammatory diseases and thyroid diseases within the last years Use of drugs known to affect glycemic control, beta blockers, any change in daily activity profile, and diet

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3g CLA<br>3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, 100 IU vitamin E | Dietary Supplement: Tonalin SG1000T FFA<br> <br> |
| Active Comparator: 3 g CLA<br>3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, vitamin E placebo | Dietary Supplement: Tonalin SG1000T FFA<br> <br> |
| No Intervention: 3 g MCT + vit E placebo<br>3 g MCT AND other diabetes medication currently prescribed to participant, 100 IU vitamin E placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin sensitivity |  |  | 
| beta cell function |  |  | 
| glycosylated hemoglobin |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin) |  |  | 
| systolic and diastolic blood pressure |  |  | 
| serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100) |  |  | 
| fibrinogen, PAI-1 |  |  | 
| body fat using bioimpedance |  |  | 
| oxidative stress (MDA) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus, CLA, Antioxidant, Glycemic control