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NCT01083108 · ClinicalTrials.gov registry record · Phase 2
Effects of Caloric Restriction Alone Versus Postoperative Caloric Restriction Following Bariatric Surgery on Glucose Metabolism in Patients With Diabetes Mellitus
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01083108 is a Phase 2 study that was terminated before completion, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 5 participants.
The verdict
NCT01083108, a Phase 2 study, was terminated before completion, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: * Bariatric surgery is the most effective way to achieve significant, long-term weight loss. It has also been shown to be an effective therapy for obese individuals with type 2 diabetes: more than 70 percent of patients no longer need medications for diabetes after surgery. This resolution of diabetes is predominately caused by marked weight loss resulting in improved insulin sensitivity. However, the beneficial effects of bariatric surgery on type 2 diabetes cannot be accounted for entirely by weight loss, because many bariatric surgery patients have resolution of diabetes within 1 week following bariatric surgery, even before they lose a clinically significant amount of weight. * One possible reason for the rapid resolution of diabetes after bariatric surgery .is that during the first week after surgery, patients can eat very little (about 300 Calories per day). It is well known that reducing calories to this level improves diabetes. Another possibility is that changes in the flow of food through the intestines may improve diabetes. Evidence for this comes from the observation that patients after gastric bypass have better glucose levels than those who have gastric banding. Researchers are interested in determining how much of the improvement in diabetes in the first week after Roux-en-Y gastric bypass (RYGBP) surgery is due to restricting calories, and how much is due to other factors, such as bypassing the upper part of the small intestine. Objectives: * To determine the change in total body insulin sensitivity after RYGBP compared to caloric restriction without surgery. * To study possible reasons for improvements in diabetes after RYGBP. Eligibility: \- Individuals 18 to 60 years of age who have a body mass index (BMI) greater than 35 and have type 2 diabetes. Design: \- This is not a randomized study, and patients will not receive bariatric surgery as part of this study. Two groups of patients will be studied: those scheduled for RYGBP sur
Interventions
- OTHER Caloric Restriction
- OTHER Roux-en-Y Gastric Bypass
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2011-03-31 |
| Est. Completion | 2019-12-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01083108
The ClinicalTrials.gov registry entry for NCT01083108 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Caloric Restriction is the first listed.
NCT01083108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01083108 about?
NCT01083108 is a clinical study titled "Effects of Caloric Restriction Alone Versus Postoperative Caloric Restriction Following Bariatric Surgery on Glucose Metabolism in Patients With Diabetes Mellitus". Background: * Bariatric surgery is the most effective way to achieve significant, long-term weight loss. It has also been shown to be an effective therapy for obese individuals with type 2 diabetes: more than 70 percent of patients no longer need medications for diabetes after surgery. This resolut...
What is the current status of trial NCT01083108?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2011-03-31. Estimated completion is 2019-12-13.
What interventions are being tested in trial NCT01083108?
The interventions under investigation include: Caloric Restriction (OTHER), Roux-en-Y Gastric Bypass (OTHER).
Who is sponsoring clinical trial NCT01083108?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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