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

Liverpool University Hospitals NHS Foundation Trust

Status

Unknown

Conditions

Adipose Tissue

Treatments

Other: GIP (glucose dependent insulinotropic peptide) infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00809029

08DE001

08/H1001/20

Details and patient eligibility

About

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

Enrollment

12 estimated patients

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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)