Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: January 19, 2016
Last verified: January 2016

August 11, 2009
January 19, 2016
February 2010
November 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00957957 on ClinicalTrials.gov Archive Site
Change from baseline in PYY measured by dMS 4 weeks after RYGBP [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)
Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes
This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
Morbidly obese type 2 diabetic patients
  • Obesity, Morbid
  • Diabetes Mellitus Type 2
Not Provided
  • 1
    Participants having elective Roux-en-Y gastric bypass surgery (RYGBP)
  • 2
    Participants having elective gastric banding surgery (GB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00957957
0000-134, 2009_002
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP