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

This study will examine changes in various gut-derived hormones in obese type 2 diabetic patients before and after elective bariatric surgery.

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Key information

Conditions

Obesity, Morbid Body Weight Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change from baseline in PYY (Peptide YY) measured by ELISA 4 weeks after RYGBP

Time frame: Baseline and Week 4

Secondary outcomes

Change from baseline in PYY measured by dMS 4 weeks after RYGBP

Time frame: Baseline and week 4

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Gut Hormone Profiling in Peripheral Blood After Bariatric Surgery in Obese Patients With Type 2 Diabetes

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Aug 13, 2009
Registry last updated: Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed