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| Name | Class |
|---|---|
| Neuropsychiatric Research Institute, Fargo, North Dakota | OTHER |
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The purpose of this study is to investigate a persons dietary intake and its effect on the gut microbiome and the association of those two variables on weight and glucoregulation. Specifically, the investigators will compare the gut microbiota, fasting glucose and insulin, c-peptide and hemoglobin A1-c in three groups of subjects: obese patients (BMI ≥ 30 kg/m2) with type 2 diabetes mellitus (T2DM), obese patients without T2DM, and normal weight lean controls without T2DM. Each patient will also complete a detailed dietary recall (ASA-24) to investigate the association with diet, microbiome and weight/glucoregulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Obese patients (BMI greater than or equal to 30 kg/m2) with Type 2 Diabetes Mellitus. |
| |
| 2 | Obese patients (BMI greater than or equal to 30 kg/m2) without Type 2 Diabetes Mellitus. |
| |
| 3 | Normal weight lean controls without Type 2 Diabetes Mellitus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention used | Other | Patients will be giving a blood sample after 8 hours of fasting. |
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| Measure | Description | Time Frame |
|---|---|---|
| Intestinal Microbiome Composition | The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation. | One sample collected upon study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose | Serum glucose (fasting) will be measured from collected blood sample and compared between the 3 subject groups. | One sample collected upon study enrollment |
| Fasting Insulin | Plasma insulin (fasting) will be measured from collected blood sample and compared between the 3 subject groups. |
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Inclusion Criteria:
Exclusion Criteria:
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Obese diabetics, obese non-diabetics and controls
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Research Institute (NRI) | Fargo | North Dakota | 58103 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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plasma/serum samples and fecal samples will be collected from each patient.
| One sample collected upon study enrollment |
| C-peptide | c-peptide will be measured from collected blood sample and compared between the 3 subject groups. | One sample collected upon study enrollment |
| Hemoglobin A1-c | hemoglobin A1-c will be measured from collected blood sample and compared between the 3 subject groups. | One sample collected upon study enrollment |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |