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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00957957
First received: August 11, 2009
Last updated: December 5, 2014
Last verified: December 2014
History of Changes
  Purpose

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


Condition
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in PYY measured by dMS 4 weeks after RYGBP [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
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)
Groups/Cohorts
1
Participants having elective Roux-en-Y gastric bypass surgery (RYGBP)
2
Participants having elective gastric banding surgery (GB)

  Eligibility
Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Morbidly obese type 2 diabetic patients

Criteria

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 ClinicalTrials.gov identifier: NCT00957957

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00957957     History of Changes
Other Study ID Numbers: 0000-134, 2009_002
Study First Received: August 11, 2009
Last Updated: December 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on March 01, 2015