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

June 14, 2011 updated by: Shahid Beheshti University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
insulin sensitivity
beta cell function
glycosylated hemoglobin

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

April 5, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (Estimate)

April 6, 2010

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2387

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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