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

NCT ID: NCT00625040

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-01-31

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.

Conditions

Obesity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

A

Obese patients without diabetes with a Body Mass Index \> 37 kg/m2

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

Intervention Type: OTHER

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.

Interventions

Oral 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Copenhagen

OTHER

Sponsor Role: collaborator

European Foundation for the Study of Diabetes

OTHER

Sponsor Role: collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Katrine Bagge Hansen

MD, Ph.d

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katrine Bagge Hansen, MD

Role: PRINCIPAL_INVESTIGATOR

Glostrup University Hospital, Copenhagen

Filip K Knop, MD, PhD

Role: STUDY_DIRECTOR

Gentofte Hospital

Steen Larsen, MD, DMSc

Role: STUDY_DIRECTOR

Glostrup University Hospital, Copenhagen

Jens Juul Holst, MD,DMSc

Role: STUDY_DIRECTOR

University of Copenhagen

Viggo Kristensen, MD

Role: STUDY_CHAIR

Glostrup University Hospital, Copenhagen

Locations

Glostrup Hospital

Glostrup Municipality, , Denmark

Countries

Denmark

Other Identifiers

GB-INK

Identifier Type: -

Identifier Source: org_study_id