Clinical trial NCT01099163: Effect of Conjugated Linoleic Acid Alone and in Conjunction With Vitamin E in Patients With Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes mellitus
CLA
Antioxidant
Glycemic control
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: insulin sensitivity
measure: beta cell function
measure: glycosylated hemoglobin
Secondary outcomes:
measure: inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin)
measure: systolic and diastolic blood pressure
measure: serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100)
measure: fibrinogen, PAI-1
measure: body fat using bioimpedance
measure: oxidative stress (MDA)
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Taleghani Hospital
Study officials:
References: