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

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ClinicalTrials.gov Identifier: NCT01099163
Recruitment Status : Completed
First Posted : April 6, 2010
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Dietary Supplement: Tonalin SG1000T FFA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : January 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

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



Primary Outcome Measures :
  1. insulin sensitivity
  2. beta cell function
  3. glycosylated hemoglobin

Secondary Outcome Measures :
  1. inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin)
  2. systolic and diastolic blood pressure
  3. serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100)
  4. fibrinogen, PAI-1
  5. body fat using bioimpedance
  6. oxidative stress (MDA)


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099163


Locations
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Iran, Islamic Republic of
Taleghani Hospital
Tehran, Iran, Islamic Republic of, 1981619573
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

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Responsible Party: Reza Rastmanesh, Ph.D, National Nutrition and Food Technology Research Institute
ClinicalTrials.gov Identifier: NCT01099163     History of Changes
Other Study ID Numbers: 2387
First Posted: April 6, 2010    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: April 2010

Keywords provided by Shahid Beheshti University of Medical Sciences:
Diabetes mellitus
CLA
Antioxidant
Glycemic control

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents