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Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134 AM2)

This study is currently recruiting participants.
Verified September 2012 by Merck
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00957957
First received: August 11, 2009
Last updated: September 25, 2012
Last verified: September 2012
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:

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 ]

Estimated Enrollment: 22
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957957

Contacts
Contact: Toll Free Number 1-888-577-8839

Locations
United States, Indiana
Call for Information (Investigational Site 0003) Recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00957957     History of Changes
Other Study ID Numbers: 0000-134, 2009_002
Study First Received: August 11, 2009
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013