Dietary Fatty Acids As Complementary Therapy in Type 2 Diabetes Mellitus

NCT00607945 | Completed Phase 1 DMC

• 3 other identifiers: 2007H0185R21AT003520-01A25R21AT003520
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see how a dietary oil called conjugated linoleic acid, or CLA, might be useful in combination with diabetes medication. Some studies show that CLA can modestly reduce body weight and body fat. Our research idea is that taking CLA will reduce body weight and body fat without interfering with the diabetes medications' effects on blood sugar.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; conjugated linoleic acid; weight loss; rosiglitazone; glucose control; insulin sensitivity

Outcome Measures

Primary Outcomes (1)

• Difference in change in body weight of the intervention groups

  Between baseline and week 32, or end of study

Secondary Outcomes (18)

• Change in fat mass

  Between baseline and week 32

• Change in lean mass

  Between baseline and week 32

• Change in insulin sensitivity

  Between week 0 and week 32

• Change in lipid profile (TChol, LDL, HDL, C-reactive protein)

  Weeks -4, -1, 0, 8, 16, 24, 31, 32

• Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin)

  Weeks -4, -1, 0, 8, 16, 24, 31, 32

Study Arms (3)

0 g CLA

PLACEBO COMPARATOR

Avandia (Rosiglitazone) 4-8mg/day OR other diabetes medication currently prescribed to participant, 0 g CLA, 8 g Placebo oil (based on typical American diet)

Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant

3.2 g CLA

EXPERIMENTAL

Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 3.2 g CLA, 4.8 g placebo oil (based on typical American diet)

Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant; Dietary Supplement: conjugated linoleic acid (CLA)

6.4 g CLA

EXPERIMENTAL

Avandia 4-8mg/day OR other diabetes medication currently prescribed to participant, 6.4 g CLA, 1.6 g placebo oil (based on typical American diet)

Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant; Dietary Supplement: conjugated linoleic acid (CLA)

Interventions

Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant DRUG

Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32

Also known as: Avandia

0 g CLA; 3.2 g CLA; 6.4 g CLA

conjugated linoleic acid (CLA) DIETARY_SUPPLEMENT

3.2 g/day, capsule, week 0 to week 32

Also known as: Tonalin, Clarinol

3.2 g CLA

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus
• HbA1c ≤ 9%
• Overweight or obese (BMI ≥ 25 kg/m2 and ≤ 45 kg/m2)
• Age ≥ 30 and ≤ 70 years (postmenopausal if female)
• Stable medical therapy for past 3 months
• Stable body weight (within ± 2 kg) for past 3 months
• Plans to remain in the Columbus, OH metropolitan area for at least 1 year

You may not qualify if:

• Substance abuse
• Current use of prescription or over-the-counter medications or supplements known to affect body composition
• Current use of prescription or over-the-counter medications or supplements known to interact with thiazolidinediones(TZDs)
• Current or previous diagnosis of congestive heart failure
• Self-report of claustrophobia
• Abnormal liver function
• Impaired cognitive function
• Current or previous diagnosis of renal disease
• Gastrointestinal diseases or disorders
• Current use of hormone therapies, or use within the past 3 months
• Discontinuation of diabetes medication

Sponsors & Collaborators

• Ohio State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• GlaxoSmithKline: collaborator
• Bunge Loders Croklaan: collaborator
• LifeScan: collaborator

Study Sites (1)

The Ohio State University Clinical Research Center (Davis Medical Research Center)

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Weight Loss; Insulin Resistance

Interventions

Rosiglitazone; Linoleic Acids, Conjugated

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Linoleic Acids; Fatty Acids, Omega-6; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Martha A Belury, PhD, RD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 6, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (1)