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Mixed Meal Tolerance test, Hyperglycemic clamp · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Lap-band | ACTIVE_COMPARATOR | Patient undergoing Lap-band Bariatric Surgery |
| Gastric Bypass | ACTIVE_COMPARATOR | Patient's undergoing Laparoscopic Roux-N Y Gastric Bypass surgery. |
| Name | Type | Description |
|---|---|---|
| Mixed Meal Tolerance test, Hyperglycemic clamp | PROCEDURE | Subjects undergo a standard mixed meal tolerance test \& hyperglycemic clamp to assess insulin secretion \& sensitivity (whole body glucose disposal) pre-op. Following surgery, at 1week, 1 month, 6 months and 12 months subjects will undergo hyperglycemic clamp \& mixed meal tolerance test. During these tests, measurements will include plasma levels of glucose, insulin, C-peptide, free fatty acid levels and adipocyte hormone profile (adiponectin, leptin, resistin). A gut hormone profile (ghrelin, glucagons-like-peptide 1 GLP-1, glucose-dependent insulinotropic polypeptide GIP, PYY) will be performed at fasting \& specific postprandial times. Results will be compared between two groups: patients undergoing laparoscopic Roux-en-Y gastric bypass \& gastric banding. |
Inclusion Criteria: * Negative pregnancy test if female * ADA criteria for diabetes type II * Hematocrit \> 35 creatinine \< 1.9, AST \< 3X upper limit of normal, ALT \< 3X upper limit of normal, alkaline phos \<3X upper limit of normal * Eligibility for bariatric surgery based on the NIH and clini...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
Mixed Meal Tolerance test, Hyperglycemic clamp is used in the study of glucose metabolism in patients with diabetes and gastric bypass. It was evaluated in a clinical trial to assess glucose metabolism in the immediate and short term follow up after bariatric surgery.
Mixed Meal Tolerance test, Hyperglycemic clamp is developed by Community Health Systems, Inc. (NYSE: CYH). The company sponsored a clinical trial to evaluate the test in the context of diabetes and gastric bypass.
Mixed Meal Tolerance test, Hyperglycemic clamp is in Phase 1 clinical development. It is an investigational test and has not been approved by the FDA. The Phase 1 trial has been completed.
Mixed Meal Tolerance test, Hyperglycemic clamp was studied in clinical trial NCT00488423, titled "Glucose Metabolism in the Immediate and Short Term Follow up After Bariatric Surgery." This Phase 1 trial enrolled 21 participants with diabetes and gastric bypass in the United States and has been completed.
Mixed Meal Tolerance test and Hyperglycemic clamp are distinct procedures used to assess glucose metabolism. The clinical trial NCT00488423 used these tests to evaluate glucose metabolism after bariatric surgery in patients with diabetes.