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Clinical Trial Summary

Study part-1

GIP (glucose-dependent insulinotropic polypeptide) is one of the two main incretin hormones secreted by specialized cells of the gastrointestinal tract in response to ingestion of nutrients. Data emerging from studies in animal models and cultured human fat cells support a physiological role for GIP in the adipose tissue metabolism which may contribute to the pathogenesis of obesity.

The proposed study will shed more light on the interactions between gut hormones and adipose tissue. For this pilot study, male subjects fulfilling the inclusion criteria will be given GIP or placebo infusions in a randomized manner. Fat tissue biopsies will be obtained from all subjects during both visits, once in the basal state (before the start of the peptide/placebo infusion) and then repeated at the end of the period of infusion.

Study part-2

Surgery represents the most effective therapeutic modality for morbid obesity. Resolution of type 2 diabetes mellitus (T2DM) has been consistently observed as an additional benefit of surgical treatment of obesity. The mechanisms underlying the dramatic effects of surgery on insulin sensitivity and β-cell function are poorly understood. Bariatric surgery (gastric bypass) promotes changes in the enteroendocrine system as a result of nutrient diversion from the physiological intestinal routes with subsequent profound modification of gut hormone secretion

We hypothesize that restoration of GIP action after bariatric procedures plays a cardinal role in the improvement and/or restoration of diabetes, we propose to study patients (both sex)with morbid obesity and T2DM within 3 months after their surgery. Their responses will be compared to those of BMI matched control subjects with normal glucose tolerance


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT00809029
Study type Interventional
Source Aintree University Hospitals NHS Foundation Trust
Contact CHRISTINA DAOUSI, MD FRCP
Phone +44 (0) 151 529 5920
Email cdaousi@liverpool.ac.uk
Status Recruiting
Phase N/A
Start date April 2011
Completion date December 2012

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