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Completed

NCT Number: NCT01121471

Supplementation With Conjugated Linoleic Acid (CLA) as Complementary Therapy in the Management of Type 2 Diabetes Mellitus (Women's Diabetes Study)

The purpose of this study is to determine the role of CLA as a complementary therapy to improve body composition, glucose tolerance, fasting plasma glucose and insulin, and hemoglobinA1c (HbA1c) in subjects with type 2 diabetes mellitus (T2DM).

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

The design is a double-blind, placebo-controlled, crossover study conducted at a single site. The primary variable is a change from baseline to Week 16 in plasma glucose area under the curve during a three-hour oral glucose tolerance test. Secondary variables include changes in fasting levels of glucose and insulin, glucose tolerance, hemoglobinA1c, hepatic enzymes, adipocytokines, blood lipid profile, and body composition. Supporting endpoints include dietary intake, physical activity, fatty acids, and vital signs.

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
  • obese
  • postmenopausal
  • HbA1c >6.49 and <14.1

Exclusion criteria

  • use of tobacco
  • substance abuse
  • impaired cognitive function
  • renal disease
  • abnormal liver function
  • gastrointestinal diseases
  • use of exogenous insulin
  • use of hormone replacement therapy currently or within past 6 months
  • pacemaker/defibrillator

Treatment and study plan

conjugated linoleic acid (CLA)

Dietary Supplement

6.4 g CLA/day, capsule form, for 16 week arms

Safflower oil

Dietary Supplement

8.0g/day safflower oil

Primary outcomes

  1. change in plasma glucose AUC

    Time frame: baseline and week 16

    significant change in plasma glucose AUC (0-3 h) from baseline to Week 16.

Secondary outcomes

  1. change in insulin sensitivity

    Time frame: baseline and every 4 weeks until week 16

  2. change in glucose tolerance

    Time frame: baseline and every 4 weeks for 16 weeks

  3. change in HbA1c

    Time frame: baseline and week 16

  4. change in blood lipid profile

    Time frame: baseline and every 4 weeks for 16 weeks

  5. change in serum adipocytokines

    Time frame: baseline and every 4 weeks for 16 weeks

  6. change in hepatic enzymes

    Time frame: baseline and every 4 weeks for 16 weeks

  7. change in body composition

    Time frame: baseline and every 4 weeks for 16 weeks

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Cognis

Registry information

Acronym: WDS

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
May 12, 2010
Registry last updated
May 12, 2010

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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