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Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus (FACT)

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Alternative Medicine (NCCAM)
GlaxoSmithKline
Loders Croklaan
LifeScan
Information provided by (Responsible Party):
Martha Belury, Ohio State University
ClinicalTrials.gov Identifier:
NCT00607945
First received: January 24, 2008
Last updated: September 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Rosiglitazone (Avandia) OR other diabetes medication currently prescribed to participant
Dietary Supplement: conjugated linoleic acid (CLA)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Difference in change in body weight of the intervention groups [ Time Frame: Between baseline and week 32, or end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in fat mass [ Time Frame: Between baseline and week 32 ] [ Designated as safety issue: No ]
  • Change in lean mass [ Time Frame: Between baseline and week 32 ] [ Designated as safety issue: No ]
  • Change in insulin sensitivity [ Time Frame: Between week 0 and week 32 ] [ Designated as safety issue: No ]
  • Change in lipid profile (TChol, LDL, HDL, C-reactive protein) [ Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32 ] [ Designated as safety issue: Yes ]
  • Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin) [ Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32 ] [ Designated as safety issue: No ]
  • Changes in liver enzymes (ALT and AST) [ Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32 ] [ Designated as safety issue: Yes ]
  • Edema [ Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32 ] [ Designated as safety issue: Yes ]
  • Change in glucose control [ Time Frame: Weeks -1, 16, 31 ] [ Designated as safety issue: No ]
  • Change in bone density, bone formation and resorption markers [ Time Frame: Weeks -4, -1, 31 ] [ Designated as safety issue: No ]
  • Change in C-Peptide [ Time Frame: Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32 ] [ Designated as safety issue: No ]
  • Diabetes coping behaviors and self-efficacy [ Time Frame: Weeks -4, -1, 32 ] [ Designated as safety issue: No ]
  • Chronic stress (as measured by questionnaire) [ Time Frame: Weeks -4 and 32 ] [ Designated as safety issue: No ]
  • Appetite (as measured by appetite rating scale) [ Time Frame: Weeks -4, 0, 16, 32 ] [ Designated as safety issue: No ]
  • EKG [ Time Frame: Weeks -4, 16, 32 ] [ Designated as safety issue: Yes ]
  • BNP (brain type natriuretic peptide) [ Time Frame: Weeks -4 and 32 ] [ Designated as safety issue: Yes ]
  • Energy balance (physical activity recalls, food records, indirect calorimetry) [ Time Frame: Weeks -1, 16, 31 ] [ Designated as safety issue: No ]
  • Compliance (fatty acid composition, pill counts) [ Time Frame: Weeks -1, 0, 8, 16, 24, 31, 32 ] [ Designated as safety issue: No ]
  • Nutrition knowledge [ Time Frame: Weeks -4, 0, 32 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0 g CLA
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
Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Other Name: Avandia
Experimental: 3.2 g CLA
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
Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Other Name: Avandia
Dietary Supplement: conjugated linoleic acid (CLA)
3.2 g/day, capsule, week 0 to week 32
Other Name: Tonalin, Clarinol
Experimental: 6.4 g CLA
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
Rosiglitazone 4-8mg/day, pill, from week -4 to week 32 OR other diabetes medication taken as prescribed from week -4 to week 32
Other Name: Avandia
Dietary Supplement: conjugated linoleic acid (CLA)
6.4 g/day, capsule, week 0 to week 32
Other Name: Tonalin, Clarinol

Detailed Description:

The long term goal of this research is to develop effective complementary strategies to aid in the management of type 2 diabetes (T2DM). Our central hypothesis is that CLA reduces body weight and body fat mass when administered concomitantly with oral diabetes medication, The rationale of this study is that using CLA to reduce body weight and body fat in people with T2DM may improve efficacy and longevity of the oral diabetes medications in the management of T2DM. We plan to test our central hypothesis and accomplish the overall objective of this research by pursuing the following three specific aims.

Specific Aim 1: Determine the ability of CLA to reduce body weight and body fat mass in people using oral diabetes medication for management of T2DM.

Specific Aim 2: Determine the ability of CLA to modulate insulin sensitivity when combined with oral diabetes medication.

Specific Aim 3: Determine the safety and tolerability of CLA in combination with oral diabetes medication.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607945

Locations
United States, Ohio
The Ohio State University Clinical Research Center (Davis Medical Research Center)
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Center for Complementary and Alternative Medicine (NCCAM)
GlaxoSmithKline
Loders Croklaan
LifeScan
Investigators
Principal Investigator: Martha A Belury, PhD, RD The Ohio State University Department of Human Nutrition
  More Information

Additional Information:
The Ohio State University College of Education and Human Ecology Clinical Studies Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Martha Belury, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00607945     History of Changes
Other Study ID Numbers: 2007H0185, R21AT003520-01A2, 5R21AT003520
Study First Received: January 24, 2008
Last Updated: September 5, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Ohio State University:
Type 2 diabetes mellitus
conjugated linoleic acid
weight loss
 rosiglitazone
glucose control
insulin sensitivity

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013