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

Obesity, Morbid Clinical Trial

Official title:

Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00957957
• Other study ID #: 0000-134
• Secondary ID: 2009_002
• Status: Completed
• Phase: N/A
• First received: August 11, 2009
• Last updated: January 19, 2016
• Start date: February 2010
• Est. completion date: November 2014

Study information

• 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

Clinical Trial Summary

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

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2
• Obesity, Morbid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

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