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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00957957
First received: August 11, 2009
Last updated: November 13, 2014
Last verified: November 2014

August 11, 2009
November 13, 2014
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 ]
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 ]
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 ]
Change from baseline in PYY measured by dMS 4 weeks after RYGBP [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
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.
 
Active, not recruiting
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
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00957957
0000-134, 2009_002
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2014

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