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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099163
• Other study ID #: 2387
• Status: Completed
• Phase: N/A
• First received: April 5, 2010
• Last updated: June 14, 2011
• Start date: January 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2010
• Source: hahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Dietary Supplement:
• Tonalin SG1000T FFA

Locations

Country	Name	City	State
Iran, Islamic Republic of	Taleghani Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity			No
Primary	beta cell function
Primary	glycosylated hemoglobin
Secondary	inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin)
Secondary	systolic and diastolic blood pressure
Secondary	serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100)
Secondary	fibrinogen, PAI-1
Secondary	body fat using bioimpedance
Secondary	oxidative stress (MDA)