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Hormone Therapy
Saline for Obesity
Phase 1
Waitlist Available
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight ≤ 200 kg
Age 21-65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month (before and after surgery)
Awards & highlights
Study Summary
This trial will study if there is a difference in the hormones secreted by the stomach before and after bariatric surgery, which could impact weight loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month (before and after surgery)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month (before and after surgery)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in plasma glucose levels with ghrelin versus saline.
Secondary outcome measures
Plasma insulin levels
Other outcome measures
Acyl and desacyl ghrelin
Performance on Visual Analog Scale for Hunger
Plasma Levels of Bile Acids
+14 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Vertical Sleeve Gastrectomy (VSG) PO/POExperimental Treatment3 Interventions
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
Group II: Vertical Sleeve Gastrectomy (VSG) NJ/POExperimental Treatment3 Interventions
Patients that are undergoing routine VSG will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
Group III: Roux-en-Y Gastric Bypass (RYGB) PO/POExperimental Treatment3 Interventions
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed.
Group IV: Roux-en-Y Gastric Bypass (RYGB) NJ/POExperimental Treatment3 Interventions
Patients that are undergoing routine RYGB will be studied preoperatively, and at 1 month postoperatively. Each time point will have two study visits with a cross-over design. The first visit at each time point will be randomized to a human ghrelin or a saline infusion, with the alternate infusion at the second visit. At each study visit, an Oral Glucose Tolerance Test (OGTT) will be performed by administering glucose through a nasojejunal (NJ) feeding tube preoperatively and orally (PO) postoperatively.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Saline
2013
Completed Phase 4
~1050
Human Ghrelin
2016
Completed Phase 1
~70
Oral Glucose Tolerance Test (OGTT)
2020
Completed Phase 1
~580
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,342 Previous Clinical Trials
4,314,176 Total Patients Enrolled
441 Trials studying Obesity
588,171 Patients Enrolled for Obesity
Vanderbilt University Medical CenterLead Sponsor
851 Previous Clinical Trials
669,067 Total Patients Enrolled
35 Trials studying Obesity
6,811 Patients Enrolled for Obesity
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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