Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 11, 2009
Last updated: January 19, 2016
Last verified: January 2016
This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.

Obesity, Morbid
Diabetes Mellitus Type 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP [ Time Frame: Baseline and Week 4 ]

Secondary Outcome Measures:
  • Change from baseline in PYY measured by dMS 4 weeks after RYGBP [ Time Frame: Baseline and week 4 ]

Enrollment: 22
Study Start Date: February 2010
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Participants having elective Roux-en-Y gastric bypass surgery (RYGBP)
Participants having elective gastric banding surgery (GB)


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Morbidly obese type 2 diabetic patients

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
  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 identifier: NCT00957957

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00957957     History of Changes
Other Study ID Numbers: 0000-134
2009_002 ( Other Identifier: Merck )
Study First Received: August 11, 2009
Last Updated: January 19, 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Nutrition Disorders
Body Weight
Signs and Symptoms
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on May 22, 2017