Incretin Physiology and Beta-cell Function Before and After Weight-loss

Incretin Physiology and Beta-cell Function Before and After Weight-loss - Effects of Long-term Weight Loss Following Laparoscopic Adjustable Gastric Banding

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00625040

Enrollment

Registered

2008-02-28

Start date

2008-01-31

Completion date

2011-01-31

Last updated

2014-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Incretin effect, Gastric banding, Glucagon, Glucagon-Like Peptide 1, Gastric Inhibitory Peptide, Glucose Intestinal Peptide, Insulin, C-peptide

Brief summary

To evaluate the impact of laparoscopic adjustable gastric banding (LAGB) on beta-cell function, insulin sensitivity, incretin function, postprandial secretion of incretin hormones (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)) in morbidly obese patients and to describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.

Detailed description

Morbid obesity represents a serious health issue in Western countries, with a rising incidence and a strong association with increased mortality and serious co-morbidities, such as diabetes. Surgical interventions, such as laparoscopic gastric banding have been developed with the aim of providing a laparoscopic placed device that is safe and effective in generating substantial weight loss. By investigation of the incretin effect, the secretion of GIP and GLP-1, the insulin response and sensitivity and the beta-cell responsiveness to glucose in 10 obese patients without type 2 diabetes before and after laparoscopic gastric banding the aim of this project is describe the pathophysiological mechanisms involved in the amelioration of glucose homeostasis during long-term weight loss.

Interventions

OTHEROral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate

OGTT: The test is performed with 50 g of glucose deluded in 300 ml water Isoglycemic iv. clamp: Iv. glucose infusion mimicking the glucose response curves from the OGTT Liquid Meal test: The test is performed with 100g of formula milk deluded in 300 ml. water Gastric Emptying Rate: Paracetamol absorption test.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Caucasians without type 2 diabetes mellitus * Normal OGTT (75 g of glucose) according to WHO's criteria * Patients fulfilling the criteria for laparoscopic gastric banding * Normal Hemoglobin * Informed consent

Exclusion criteria

* Liver disease (ALAT \> 2 x normal level) * Nephropathy (s-creatinin \> 130 µM or albuminuria) * Relatives (parents/siblings) with T2DM * Medical treatment witch cannot be stopped for 12 hours

Design outcomes

Primary

Measure	Time frame
Incretin effect before and one year after gastric banding in obese patients without diabetes	One year

Secondary

Measure	Time frame
GLP-1 and GIP response curves	One year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026