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| ID | Type | Description | Link |
|---|---|---|---|
| R21AT003520-01A2 | U.S. NIH Grant/Contract | View source | |
| 5R21AT003520 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| GlaxoSmithKline | INDUSTRY |
| Bunge Loders Croklaan | INDUSTRY |
| LifeScan |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| 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) |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in change in body weight of the intervention groups | Between baseline and week 32, or end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fat mass | Between baseline and week 32 | |
| Change in lean mass | Between baseline and week 32 | |
| Change in insulin sensitivity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha A Belury, PhD, RD | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Clinical Research Center (Davis Medical Research Center) | Columbus | Ohio | 43210 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D015431 | Weight Loss |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| D044243 | Linoleic Acids, Conjugated |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| INDUSTRY |
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|
| conjugated linoleic acid (CLA) | Dietary Supplement | 3.2 g/day, capsule, week 0 to week 32 |
|
|
| conjugated linoleic acid (CLA) | Dietary Supplement | 6.4 g/day, capsule, week 0 to week 32 |
|
|
| 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 |
| Changes in liver enzymes (ALT and AST) | Weeks -4, -1, 0, 8, 16, 24, 31, 32 |
| Edema | Weeks -4, -1, 0, 8, 16, 24, 31, 32 |
| Change in glucose control | Weeks -1, 16, 31 |
| Change in bone density, bone formation and resorption markers | Weeks -4, -1, 31 |
| Change in C-Peptide | Weeks - 4, -1, 0, 1, 8, 16, 24, 31, 32 |
| Diabetes coping behaviors and self-efficacy | Weeks -4, -1, 32 |
| Chronic stress (as measured by questionnaire) | Weeks -4 and 32 |
| Appetite (as measured by appetite rating scale) | Weeks -4, 0, 16, 32 |
| EKG | Weeks -4, 16, 32 |
| BNP (brain type natriuretic peptide) | Weeks -4 and 32 |
| Energy balance (physical activity recalls, food records, indirect calorimetry) | Weeks -1, 16, 31 |
| Compliance (fatty acid composition, pill counts) | Weeks -1, 0, 8, 16, 24, 31, 32 |
| Nutrition knowledge | Weeks -4, 0, 32 |
| D004700 | Endocrine System Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008041 | Linoleic Acids |
| D043371 | Fatty Acids, Omega-6 |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |