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Sponsored by: |
National Center for Research Resources (NCRR) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00568620 |
In parallel with the increasing prevalence of obesity worldwide, type 2 diabetes mellitus (T2DM) has reached epidemic proportions. Despite a multitude of available therapies, only bariatric surgery (e.g., roux-en-Y gastric bypass (GBP)) has proven to be an effective long term treatment modality for morbid obesity. Moreover, the majority of T2DM patients who undergo GBP experience normalization of their blood glucose and are able to discontinue their anti-diabetes medications soon after the procedure. The insulin resistant state commonly seen in non-diabetic obese subjects also improves after GBP. Evidence from recent animal studies suggests that the rapid return to euglycemia seen in T2DM patients after GBP might in part result from excluding the duodenum from the flow of nutrients. With the use of enteral feeding tubes, we hope to better understand the factors in the human gut that may predispose obese individuals to the development of insulin resistance and T2DM.
Condition | Intervention |
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Insulin Resistance and Type 2 Diabetes |
Procedure: Glucose tolerance test via nasogastric feeding tube Procedure: Glucose tolerance test via nasojejunal feeding tube |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Single Blind (Subject), Crossover Assignment |
Official Title: | The Role of the Duodenum in the Pathogenesis of Insulin Resistance and Type 2 Diabetes Mellitus |
Estimated Enrollment: | 30 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Procedure: Glucose tolerance test via nasogastric feeding tube
50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; Intravenous glucose tolerance test on day 3
Procedure: Glucose tolerance test via nasogastric feeding tube
50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; intravenous glucose tolerance test on day 3
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2: Experimental |
Procedure: Glucose tolerance test via nasojejunal feeding tube
50 g glucose tolerance test on day 1; 50 g glucose tolerance test with 30 mL oil on day 2; intravenous glucose tolerance test on day 3
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Inclusion criteria for lean, healthy control subjects:
Inclusion criteria for prediabetic individuals:
Inclusion criteria for diabetic individuals:
Exclusion Criteria:
Exclusion criteria for all study subjects:
5. Prior gastric, duodenal, proximal jejunal surgery or pancreas resection 6. Known malabsorptive disorder 7. History of cancer in past 5 years 8. Renal insufficiency defined by serum creatinine > 1.5 mg/dl 9. Hepatic enzyme elevations of greater than twice the upper limits of normal 10. Current use of warfarin or clopidogrel 11. Intercurrent infections 12. Contraindication to nasogastric or nasojejunal feeding tube (e.g., deviated nasal septum, prior upper gastrointestinal bleed, or history of easy bleeding) 13. Residence outside the greater Nashville, TN area
Responsible Party: | Vanderbilt University Medical Center ( James Isbell, MD ) |
Study ID Numbers: | IRB#070770, GCRC #1710 |
Study First Received: | December 4, 2007 |
Last Updated: | June 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00568620 |
Health Authority: | United States: Federal Government |
Hyperinsulinism Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Insulin Resistance Metabolic disorder Glucose Metabolism Disorders Insulin |