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NCT00535600 · ClinicalTrials.gov registry record
Effects of Bariatric Surgery on Insulin
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 28
- Enrollment target
NCT00535600: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00535600 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00535600 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 28 participants
- Enrollment target
Study Summary
This study, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and maintaining weight loss. The study will look at how this surgery might improve how insulin (a hormone important for regulating blood sugar levels) is made and works in the body and the possible role of changes in other hormones produced by the gut (stomach and intestines). People between 18 and 50 years of age who are scheduled to have either laparoscopic adjustable BAND or Roux-en-Y gastric bypass surgery may be eligible for this study. Candidates are screened about 4 to 6 weeks before their surgery with a medical history, blood tests and an oral glucose tolerance test for diabetes. Participants spend 4 days at the CRU or 2 days overnight and an out-patient visit approximately 4 to 6 weeks before their surgery and again 3 to 6 weeks after their surgery. They return for a 4-6 hour visit at the CRU at 6 months, 1 and 2 years after surgery and for half-day outpatient visits at 3, 4 and 5 years after surgery for the following procedures: * Blood and urine tests, including a pregnancy test for women. (4-day and 2-day admissions and years, 3, 4 and 5) * DEXA, an x-ray scan to determine body fat content. (4-day and 2-day admissions and years, 3, 4 and 5) * MRI scan to measure fat tissue in the abdomen. (4-day and 2-day admissions and years, 3, 4 and 5) * Intravenous (I.V.) glucose tolerance test for risk of obesity and diabetes. A sugar solution is given through a needle in a vein of one arm and blood samples are drawn through another needle in a vein in the other arm. (4-day admissions) * Meal test to measure blood sugar and insulin and gut hormone levels after a meal. After an I.V. line is placed in an arm vein, the subject eats breakfast over 20 minutes. Blood samples are collected halfway throug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2007-09-21 |
| Est. Completion | 2014-03-19 |
What the finished NCT00535600 record still lists
NCT00535600 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 28 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00535600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00535600 about?
NCT00535600 is a clinical study titled "Effects of Bariatric Surgery on Insulin". This study, conducted at the NIH Clinical Research Unit (CRU) at the Phoenix Indian Medical Center, will compare the effects of two methods of bariatric surgery, the adjustable BAND and Roux-en-Y gastric bypass, on insulin. Bariatric surgery is a treatment for achieving and maintaining weight loss. ...
What is the current status of trial NCT00535600?
This trial is currently completed. The enrollment target is 28 participants. The study started on 2007-09-21. Estimated completion is 2014-03-19.
Who is sponsoring clinical trial NCT00535600?
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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