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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Tonalin SG1000T FFA
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Diabetes mellitus, CLA, Antioxidant, Glycemic control

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taleghani Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

3g CLA

3 g CLA

3 g MCT + vit E placebo

Arm Description

3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, 100 IU vitamin E

3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, vitamin E placebo

3 g MCT AND other diabetes medication currently prescribed to participant, 100 IU vitamin E placebo

Outcomes

Primary Outcome Measures

insulin sensitivity
beta cell function
glycosylated hemoglobin

Secondary Outcome Measures

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)

Full Information

First Posted
April 5, 2010
Last Updated
June 14, 2011
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01099163
Brief Title
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

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes mellitus, CLA, Antioxidant, Glycemic control

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3g CLA
Arm Type
Experimental
Arm Description
3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, 100 IU vitamin E
Arm Title
3 g CLA
Arm Type
Active Comparator
Arm Description
3 g CLA (50:50%) AND other diabetes medication currently prescribed to participant, vitamin E placebo
Arm Title
3 g MCT + vit E placebo
Arm Type
No Intervention
Arm Description
3 g MCT AND other diabetes medication currently prescribed to participant, 100 IU vitamin E placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Tonalin SG1000T FFA
Primary Outcome Measure Information:
Title
insulin sensitivity
Title
beta cell function
Title
glycosylated hemoglobin
Secondary Outcome Measure Information:
Title
inflammatory mediators (TNF-alpha, Il-1beta, Il-6, CRP, adiponectin, leptin)
Title
systolic and diastolic blood pressure
Title
serum lipids (TG, LDL, HDL, LDL/HDL, ApoB100)
Title
fibrinogen, PAI-1
Title
body fat using bioimpedance
Title
oxidative stress (MDA)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Taleghani Hospital
City
Tehran
ZIP/Postal Code
1981619573
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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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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