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

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ClinicalTrials.gov Identifier: NCT00607945
Recruitment Status : Completed
First Posted : February 6, 2008
Last Update Posted : March 20, 2014
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
GlaxoSmithKline
Bunge Loders Croklaan
LifeScan
Information provided by (Responsible Party):
Martha Belury, Ohio State University

Study Description
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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.

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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dietary Fatty Acids as Complementary Therapy in Type 2 Diabetes Mellitus
Study Start Date : January 2008
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Difference in change in body weight of the intervention groups [ Time Frame: Between baseline and week 32, or end of study ]

Secondary Outcome Measures :
  1. Change in fat mass [ Time Frame: Between baseline and week 32 ]
  2. Change in lean mass [ Time Frame: Between baseline and week 32 ]
  3. Change in insulin sensitivity [ Time Frame: Between week 0 and week 32 ]
  4. Change in lipid profile (TChol, LDL, HDL, C-reactive protein) [ Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32 ]
  5. Changes in adipocytokine profile (leptin, adiponectin, visfatin, and resistin) [ Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32 ]
  6. Changes in liver enzymes (ALT and AST) [ Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32 ]
  7. Edema [ Time Frame: Weeks -4, -1, 0, 8, 16, 24, 31, 32 ]
  8. Change in glucose control [ Time Frame: Weeks -1, 16, 31 ]
  9. Change in bone density, bone formation and resorption markers [ Time Frame: Weeks -4, -1, 31 ]
  10. Change in C-Peptide [ Time Frame: Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32 ]
  11. Diabetes coping behaviors and self-efficacy [ Time Frame: Weeks -4, -1, 32 ]
  12. Chronic stress (as measured by questionnaire) [ Time Frame: Weeks -4 and 32 ]
  13. Appetite (as measured by appetite rating scale) [ Time Frame: Weeks -4, 0, 16, 32 ]
  14. EKG [ Time Frame: Weeks -4, 16, 32 ]
  15. BNP (brain type natriuretic peptide) [ Time Frame: Weeks -4 and 32 ]
  16. Energy balance (physical activity recalls, food records, indirect calorimetry) [ Time Frame: Weeks -1, 16, 31 ]
  17. Compliance (fatty acid composition, pill counts) [ Time Frame: Weeks -1, 0, 8, 16, 24, 31, 32 ]
  18. Nutrition knowledge [ Time Frame: Weeks -4, 0, 32 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607945


Locations
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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 Integrative Health (NCCIH)
GlaxoSmithKline
Bunge Loders Croklaan
LifeScan
Investigators
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Principal Investigator: Martha A Belury, PhD, RD Ohio State University
More Information
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Responsible Party: Martha Belury, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT00607945    
Other Study ID Numbers: 2007H0185
R21AT003520-01A2 ( U.S. NIH Grant/Contract )
5R21AT003520 ( U.S. NIH Grant/Contract )
First Posted: February 6, 2008    Key Record Dates
Last Update Posted: March 20, 2014
Last Verified: March 2014
Keywords provided by Martha Belury, Ohio State University:
Type 2 diabetes mellitus
conjugated linoleic acid
weight loss
 rosiglitazone
glucose control
insulin sensitivity
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs