Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)
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ClinicalTrials.gov Identifier: NCT00957957 |
Recruitment Status
:
Completed
First Posted
: August 13, 2009
Last Update Posted
: January 20, 2016
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Condition or disease |
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Obesity, Morbid Diabetes Mellitus Type 2 |
Study Type : | Observational |
Actual Enrollment : | 22 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |

Group/Cohort |
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1
Participants having elective Roux-en-Y gastric bypass surgery (RYGBP)
|
2
Participants having elective gastric banding surgery (GB)
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- Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP [ Time Frame: Baseline and Week 4 ]
- Change from baseline in PYY measured by dMS 4 weeks after RYGBP [ Time Frame: Baseline and week 4 ]

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Ages Eligible for Study: | 20 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00957957
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00957957 History of Changes |
Other Study ID Numbers: |
0000-134 2009_002 ( Other Identifier: Merck ) |
First Posted: | August 13, 2009 Key Record Dates |
Last Update Posted: | January 20, 2016 |
Last Verified: | January 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 |