Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)

Completed

• Conditions: Diabetes Mellitus Type 2; Obesity, Morbid

• Registration Number: NCT00957957
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-11
• Study First Submitted QC: 2009-08-12
• Study First Posted: 2009-08-13
• Study Start: 2010-02
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP	Baseline and Week 4

Secondary Outcome Measures

Name	Time	Method
Change from baseline in PYY measured by dMS 4 weeks after RYGBP	Baseline and week 4