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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00957957
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):

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

Condition or disease
Obesity, Morbid Diabetes Mellitus Type 2

Study Design

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes
Study Start Date : February 2010
Primary Completion Date : November 2014
Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
U.S. FDA Resources

Groups and Cohorts

Participants having elective Roux-en-Y gastric bypass surgery (RYGBP)
Participants having elective gastric banding surgery (GB)

Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957957

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00957957     History of Changes
Other Study ID Numbers: 0000-134
2009_002 ( Other Identifier: Merck )
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 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