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| Sponsors and Collaborators: |
Glostrup University Hospital,Copenhagen University of Copenhagen EFSD European Foundation for the Study of Diabetes Novo Nordisk Desirée og Niels Ydes Fond |
|---|---|
| Information provided by: | Glostrup University Hospital,Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00625040 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus Obesity |
Other: Oral glucose tolerance test (OGTT), isoglycemic iv. clamp, liquid meal test, gastric emptying rate |
| Study Type: | Observational |
| Study Design: | Case Control, Cross-Sectional |
| Official Title: | Incretin Physiology and Beta-Cell Function Before and After Remission of Type 2 Diabetes - Effects of Long-Term Weight Loss Following Laparoscopic Adjustable Gastric Banding |
p-glucose, p-glucagon, p-GLP1, p-GIP, p-cpeptid, p-insulin, p-paracetamol, buffy coat, urine, whole blood sampels
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
A
Obese patients with type 2 diabetes mellitus (WHO criteria) with a Body Mass Index >37 kg/m2
|
Other: 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 artificial breast milk deluded in 300 ml. water. Gastric Emptying Rate: Paracetamol absorption test. |
|
B
Obese patients without diabetes with a Body Mass Index >37 kg/m2
|
Other: 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 artificial breast milk deluded in 300 ml. water. Gastric Emptying Rate: Paracetamol absorption test. |
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. Type 2 diabetes is associated with a significantly higher risk of micro- and macro vascular complications. The pathogenesis of type 2 diabetes is not jet established. In patients with type 2 diabetes the incretin effect is either greatly impaired or absent, and it is assumed that this could contribute to the inability of these patients to adjust their insulin secretion to their needs.
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. Investigations have proved that substantial weight loss in patients with type 2 diabetes is associated with an improved energy homeostasis and improved insulin secretion. It has also been proved that about 60% of patients with type 2 diabetes undergoing surgical intervention with gastric banding return to a normal glucose homeostasis.
This project concerns the pathogenesis of these amazing results. By investigation of the incretin effect, the secretion of GIP and GLP-1, the insulinresponse and -sensitivity and the beta-cell responsiveness to glucose in 10 obese patients with and 10 patients without type 2 diabetes before and after laparoscopic gastric banding the aim of this project is to establish whether the reduced incretin effect in patients with type 2 diabetes is a primary event leading to the disease, or a consequence of the diabetic state.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
The cases and controls are recruited from The Bariatric Clinic at Glostrup Hospital
Inclusion Criteria: (cases)
Inclusion Criteria: (controls)
Exclusion Criteria: (cases)
Exclusion Criteria: (controls)
Contacts and Locations| Contact: Katrine Bagge Hansen, MD | +4540509942 | kbaggehansen@dadlnet.dk |
| Contact: Steen Larsen, MD DMSc | +4543232805/04 | stla@glo.regionh.dk |
| Denmark | |
| Glostrup Hospital | Recruiting |
| Glostrup, Denmark, 2600 | |
| Contact: Katrine Bagge Hansen, MD +4540509942 kbaggehansen@dadlnet.dk | |
| Contact: Steen Larsen, MD, DMSc +4543232805/04 stla@glo.region | |
| Principal Investigator: Katrine Bagge Hansen, MD | |
| Principal Investigator: | Katrine Bagge Hansen, MD | Glostrup Hospital |
| Study Director: | Filip K Knop, MD, PhD | Gentofte Hospital |
| Study Director: | Steen Larsen, MD, DMSc | Glostrup Hospital |
| Study Director: | Jens Juul Holst, MD,DMSc | University of Copenhagen |
| Study Chair: | Viggo Kristensen, MD | Glostrup Hospital |
More Information
| Responsible Party: | Glostrup Hospital ( Katrine Bagge Hansen, MD ) |
| Study ID Numbers: | GB-INK |
| Study First Received: | February 19, 2008 |
| Last Updated: | March 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00625040 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
|
Incretin effect Gastric banding Glucagon Glucagon-Like Peptide 1 |
Gastric Inhibitory Peptide Glucose Intestinal Peptide Insulin C-peptide |
|
Obesity Gastric Inhibitory Polypeptide Metabolic Diseases Glucagon Diabetes Mellitus Endocrine System Diseases Overweight Insulin Glucagon-Like Peptide 1 Body Weight |
Signs and Symptoms Diabetes Mellitus, Type 2 Weight Loss Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Acetaminophen |
