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NCT Number: NCT01099163

Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E 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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taleghani Hospital

Tehran, Tehran Province, 1981619573, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tonalin SG1000T FFA

Dietary Supplement

Primary outcomes

  1. insulin sensitivity

  2. beta cell function

  3. glycosylated hemoglobin

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 6, 2010
Registry last updated
Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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