Obesity, Morbid Clinical Trial
Official title:
Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes
Verified date | January 2016 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.
Status | Completed |
Enrollment | 22 |
Est. completion date | November 2014 |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Documented type 2 diabetes with total disease duration =10 years - BMI of at least 35 kg/m^2 - Patient is a surgical candidate for either RYGBP, GBS or vertical sleeve gastrectomy (VSG) Exclusion Criteria: - Any illness that might confound the results of the study or pose additional risk to the patient by participation - History of stroke, seizures, or other major neurological disorder - History of cancer - Patient uses or has used any medication that can alter body weight - Patient is unwilling or unable to follow study procedures |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Merck Sharp & Dohme Corp. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP | Baseline and Week 4 | No | |
Secondary | Change from baseline in PYY measured by dMS 4 weeks after RYGBP | Baseline and week 4 | No |
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