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We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.
A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | ACTOS plus standard diet |
|
| B | Experimental | Actos plus structured diet |
|
| C | Experimental | Metformin plus standard diet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actos plus standard diet | Other | Actos plus standard diet |
| |
| Actos plus structured diet |
| Measure | Description | Time Frame |
|---|---|---|
| glucose | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lipids | 4 months | |
| blood pressure | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George A Bray, MD | Pennington Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20067964 | Derived | Martin CK, Gupta AK, Smith SR, Greenway FL, Han H, Bray GA. Effect of pioglitazone on energy intake and ghrelin in diabetic patients. Diabetes Care. 2010 Apr;33(4):742-4. doi: 10.2337/dc09-1600. Epub 2010 Jan 12. | |
| 19267711 | Derived | Gupta AK, Smith SR, Greenway FL, Bray GA. Pioglitazone treatment in type 2 diabetes mellitus when combined with portion control diet modifies the metabolic syndrome. Diabetes Obes Metab. 2009 Apr;11(4):330-7. doi: 10.1111/j.1463-1326.2008.00965.x. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Other |
Actos plus structured diet |
|
| Metformin plus standard diet | Other | Metformin plus standard diet |
|
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |