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

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:

MedlinePlus related topics: Hormones

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 ]

Secondary Outcome Measures:

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


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 (Adult)
Sexes Eligible for Study:	All
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


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00957957 History of Changes
Other Study ID Numbers:	0000-134 2009_002 ( Other Identifier: Merck )
Study First Received:	August 11, 2009
Last Updated:	January 19, 2016

Additional relevant MeSH terms:


Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity, Morbid Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Obesity Overnutrition	Nutrition Disorders Overweight Body Weight Signs and Symptoms Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2017

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