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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK097550 | U.S. NIH Grant/Contract | View source |
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This protocol was replaced with a different one and therefore discontinued.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Ghrelin is a hormone naturally produced in the stomach and the gut. The purpose of this research study is to determine the role of this gut hormone in the regulation of insulin secretion from the pancreas and glucose disposal after we eat. The investigators hypothesize that ghrelin has an effect on the pancreas and on how our body handles glucose after we eat. The investigators will compare insulin secretion and glucose changes during meal ingestion while either acyl ghrelin (AG) or saline (salt solution) is being infused through your vein on separate study days. AG is a form of the ghrelin hormone that has a small modification to it that allows it to bind to a specific receptor. The investigators hypothesize that AG has an effect on how the body handles glucose after a meal. AG has been approved by the U.S. Food and Drug Administration (FDA) for human research only. This study will also involve the use of a medicine called arginine, which is a naturally occurring product and found in many nutritional supplements. Its use in this study is investigational. The use of arginine helps maximize insulin release from the pancreas so the investigators can better examine whether AG affects insulin secretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group: Type 2 Diabetes Mellitus (T2DM) | Active Comparator | Subjects with Type 2 Diabetes Mellitus (T2DM). Subjects will receive AG and saline infusions, but the order of which they receive will be random and they will not be told which one they are receiving on each given visit. Arginine will be used at both study visits. |
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| Control Group | Active Comparator | Control group of healthy subjects. Subjects will receive AG and saline, but the order of which they receive will be random and they will not be told which one they are receiving on each given visit. Arginine will be used at both study visits. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synthetic human AG | Drug | Synthetic human AG (0.28 μg/kg) bolus over 1 minute followed by 2 μg/kg/hr continuous infusion for 4.5 hours. |
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| Measure | Description | Time Frame |
|---|---|---|
| Postprandial insulin secretion (ISR-meal) | Postprandial insulin secretion (ISR-meal) will be derived from plasma C-peptide concentrations during MTT (0-240 min) using deconvolution with population estimates of C-peptide clearance. | approximately 8 weeks |
| Index of β-cell sensitivity to glucose | Index of β-cell sensitivity to glucose will be calculated as incremental insulin/glucose (I/G) AUC (ΔAUCI/G). | approximately 8 weeks |
| Whole body insulin sensitivity using the Matsuda Index | The Matsuda Index is a well-known index of insulin sensitivity derived from several glucose and insulin values obtained during a mixed meal | approximately 8 weeks |
| β-cell function (DI-meal) | β-cell function (DI-meal) will be calculated as ΔAUCI/G x Matsuda Index | approximately 8 weeks |
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Inclusion Criteria:
T2DM study subjects to be considered for the study must meet the following inclusion criteria:
Control study subjects will be matched for age- (± 2 years), BMI (± 1.5 kg/m2) and gender and must meet the following inclusion criteria:
Exclusion Criteria:
All subjects will be excluded for the following reasons:
Control subjects will be excluded for the following reasons:
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| Name | Affiliation | Role |
|---|---|---|
| Jenny Tong, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center For Living | Durham | North Carolina | 27705 | United States |
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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 |
|---|---|
| D001120 | Arginine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Arginine | Drug | Arginine hydrochloride (5 g) intravenously over 45 seconds. |
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| 0.9% saline solution | Drug | A continuous infusion of 0.9% saline solution (control) for 4.5 hours. |
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| D004700 | Endocrine System Diseases |
| D000601 | Amino Acids, Essential |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |