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This randomized, double-blind placebo-controlled study is intended to observe the short-term effects of the GFL System Diet with Release supplement versus GFL System Diet with placebo on glycemic metabolism and insulin resistance in patients with Type 2 DM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RELEASE Supplement | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RELEASE | Dietary Supplement | Dietary supplement |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Blood Glucose (FBG) at approximately 4 weeks of the GFL System Diet with Release supplement versus GFL System Diet with placebo supplement | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Fructosamine between the 2 groups | 4 weeks | |
| Change from baseline in HGB A1C between the 2 groups | 4 weeks | |
| Change from baseline in Insulin Levels between the 2 groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Buynak, MD | Contact | 2194648302 | RBUYNAK@ATT.NET |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004322 | Drainage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Dietary Supplement |
Placebo |
|
| 4 weeks |
| Change from baseline in HOMA-IR between the 2 groups | 4 weeks |
| Change from baseline in Weight between the 2 groups | 4 weeks |
| Change from baseline in Body Mass Index between the 2 groups | 4 weeks |
| Change from baseline in Hip Circumference between the 2 groups | 4 weeks |
| Change from baseline in Waist Circumference between the 2 groups | 4 weeks |
| Change from baseline in Blood Pressure between the 2 groups | 4 weeks |
| Change from baseline in Heart Rate between the 2 groups | 4 weeks |
| D004700 | Endocrine System Diseases |