The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Human Adipose Tissue: An In Vivo Study

NCT00809029 | Unknown

• 2 other identifiers: 08/H1001/2008DE001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Adipose Tissue

Keywords

GIP; OBESITY; HSL; LPL; ADIPOCYTOKINES; BARIATRIC SURGERY

Outcome Measures

Primary Outcomes (1)

• To measure Lipoprotein lipase (LPL) and Hormone sensitive Lipase (HSL) activity in adipose tissue

  Before and after 4 hours of infusion

Secondary Outcomes (1)

• To determine the role of GIP in adipocytokine gene expression and secretion from human subcutaneous adipose tissue

  Baseline and after 4 hours of continuous infusion

Interventions

GIP (glucose dependent insulinotropic peptide) infusion OTHER

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.

Also known as: GIP (glucose dependent insulinotropic peptide)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lean (BMI 20-25 kg/m2) subjects with normal glucose tolerance
• 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)

You may not qualify if:

• History of severe cardiac, hepatic or renal disease
• 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)

Sponsors & Collaborators

• Liverpool University Hospitals NHS Foundation Trust: lead

Study Sites (1)

University Hospital Aintree

Liverpool, L9 7AL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Gastric Inhibitory Polypeptide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• CHRISTINA DAOUSI, MD FRCP

  UNIVERSITY HOSPITAL AINTREE NHS TRUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHRISTINA DAOUSI, MD FRCP

CONTACT

+44 (0) 151 529 5920; cdaousi@liverpool.ac.uk

Sravan K Thondam, MBBS MRCP

CONTACT

+44 (0) 151 529 6464; s.thondam@liverpool.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Senior Lecturer

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 16, 2008
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

GB (1)