Gut Hormone Profiling in Obese Patients With Type 2 Diabetes (MK-0000-134)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 ] [ 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 ]
| 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) |
| 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
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
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 |
| Study First Received: | August 11, 2009 |
| Last Updated: | January 19, 2016 |
| Health Authority: | United States: Institutional Review Board |
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 September 23, 2016