The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition
The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Johns Hopkins University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00686972
First received: May 27, 2008
Last updated: March 25, 2010
Last verified: March 2010
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Purpose
This study is being conducted to evaluate changes in sugar, metabolism, heart function and changes in body composition as patients lose weight following bariatric surgery. The investigators will compare improvements of the above changes as a function of the four different types of bariatric surgery. The investigators believe the most beneficial and safest procedure will be the Roux-en-Y.
| Condition | Intervention | Phase |
|---|---|---|
|
Bariatric Surgery |
Drug: GLP-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | The Effect of Surgically Induced Weight Loss on Endocrine Function, Cardiovascular Function and Body Composition |
Resource links provided by NLM:
Further study details as provided by Johns Hopkins University:
Primary Outcome Measures:
- Insulin secretion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: GLP-1
5 ng/kg/min, IV for 1 hour during each clamp study (7) over 2 year period.
Other Name: Glucagon-like Peptide-1
The study will also examine the response of the pancreas (the insulin-producing organ) to a sugar load, as well as to a hormone called GLP-1, which is released from your gut to maximally stimulate your pancreas. The release of this hormone increases when you eat food and it causes the pancreas to release more insulin than does sugar alone. Volunteers will have 22 visits over a two year period. Only people having Roux-en-Y gastric bypass surgery, gastric sleeve surgery, duodenal switch gastric surgery or lap-band/gastric banding surgery may join. Seventy volunteers will be recruited to take part in this study.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male and female volunteers 21-65 years.
- BMI > 40.
- Preoperative hematocrit level of at least 34% for women and 38% for men.
- Postoperative hematocrit level of at least 34% for women and 36% for men.
Exclusion Criteria:
- Volunteers whose hematocrit level does not meet the above criteria.
- Pregnant and or lactating females.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686972
Please refer to this study by its ClinicalTrials.gov identifier: NCT00686972
Locations
| United States, Maryland | |
| Johns Hopkins Bayview Medical Center | |
| Baltimore, Maryland, United States, 21224 | |
Sponsors and Collaborators
Johns Hopkins University
Investigators
| Principal Investigator: | Dariush Elahi, PhD | Johns Hopkins University |
More Information
| Responsible Party: | Dariush Elahi, PhD, Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00686972 History of Changes |
| Other Study ID Numbers: | NA_00004876 |
| Study First Received: | May 27, 2008 |
| Last Updated: | March 25, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Johns Hopkins University:
|
Bariatric Surgery Glucose Regulation Cardiac Function Body Composition |
Additional relevant MeSH terms:
|
Weight Loss Body Weight Changes Body Weight Signs and Symptoms Glucagon-Like Peptide 1 Glucagon |
Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Gastrointestinal Agents |
ClinicalTrials.gov processed this record on September 23, 2016