The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Human Adipose Tissue: An In Vivo Study
NCT ID: NCT00809029
Last Updated: 2011-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2011-04-30
2012-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Interventions
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GIP (glucose dependent insulinotropic peptide) infusion
an intravenous infusion of GIP (glucose dependent insulinotropic peptide)or placebo will be administered at a rate of 2 pmol/kg/min and maintained for 240 minutes.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Obese (BMI \>30 kg/m2) subjects also with normal glucose tolerance.
* Obese with impaired glucose tolerance
* Obese with diet controlled diabetes mellitus
* Morbid obesity, type diabetes and post bariatric surgery (study part 2)
Exclusion Criteria
* Thyroid dysfunction (hyper-or hypothyroidism), or other endocrine disturbance (acromegaly, growth hormone deficiency, hypoadrenalism or cortisol overproduction)
* Current malignant disease
* Known alcohol misuse
* Major psychiatric disease (including current use of antidepressants)
* History of major eating disorder (anorexia or bulimia nervosa)
18 Years
75 Years
MALE
No
Sponsors
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Liverpool University Hospitals NHS Foundation Trust
OTHER_GOV
Responsible Party
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DR CHRISTINA DAOUSI
Clinical Senior Lecturer
Principal Investigators
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CHRISTINA DAOUSI, MD FRCP
Role: PRINCIPAL_INVESTIGATOR
UNIVERSITY HOSPITAL AINTREE NHS TRUST
Locations
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University Hospital Aintree
Liverpool, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Christina Daousi, MD FRCP
Role: primary
Sravan K Thondam, MBBS MRCP
Role: backup
Other Identifiers
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08DE001
Identifier Type: -
Identifier Source: secondary_id
08/H1001/20
Identifier Type: -
Identifier Source: org_study_id