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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Aintree University Hospitals NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
DR CHRISTINA DAOUSI, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00809029
First received: December 15, 2008
Last updated: December 20, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention
Adipose Tissue
Other: GIP (glucose dependent insulinotropic peptide) infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Influence Of GIP (Glucose-Dependent Insulinotropic Polypeptide) Infusion On Hormone Sensitive Lipase, Lipoprotein Lipase And Adipokine Expression In Human Subcutaneous Adipose Tissue: An In Vivo Study

Resource links provided by NLM:


Further study details as provided by Aintree University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • To measure Lipoprotein lipase (LPL) and Hormone sensitive Lipase (HSL) activity in adipose tissue [ Time Frame: Before and after 4 hours of infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the role of GIP in adipocytokine gene expression and secretion from human subcutaneous adipose tissue [ Time Frame: Baseline and after 4 hours of continuous infusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: April 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 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 Name: GIP (glucose dependent insulinotropic peptide)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  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: NCT00809029

Contacts
Contact: CHRISTINA DAOUSI, MD FRCP +44 (0) 151 529 5920 cdaousi@liverpool.ac.uk
Contact: Sravan K Thondam, MBBS MRCP +44 (0) 151 529 6464 s.thondam@liverpool.ac.uk

Locations
United Kingdom
University Hospital Aintree Recruiting
Liverpool, United Kingdom, L9 7AL
Contact: Christina Daousi, MD FRCP    +44 (0) 151 5295885    cdaousi@liverpool.ac.uk   
Contact: Sravan K Thondam, MBBS MRCP    44 (0) 151 5296464    s.thondam@liverpool.ac.uk   
Principal Investigator: Christina Daousi, MD FRCP         
Sub-Investigator: Sravan K Thondam, MBBS MRCP         
Sponsors and Collaborators
Aintree University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: CHRISTINA DAOUSI, MD FRCP UNIVERSITY HOSPITAL AINTREE NHS TRUST
  More Information

No publications provided

Responsible Party: DR CHRISTINA DAOUSI, Clinical Senior Lecturer, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00809029     History of Changes
Other Study ID Numbers: 08/H1001/20, 08DE001
Study First Received: December 15, 2008
Last Updated: December 20, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Aintree University Hospitals NHS Foundation Trust:
GIP
OBESITY
HSL
LPL
ADIPOCYTOKINES
BARIATRIC SURGERY

Additional relevant MeSH terms:
Gastric Inhibitory Polypeptide
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014