Incretin Physiology and Beta-Cell Function Before and After Remission of Type 2 Diabetes
Recruitment status was Recruiting
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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: | Observational Model: Case Control Time Perspective: 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 |
- Incretin effect before and one year after gastric banding in obese patients with type 2 diabetes compared with obese patients without diabetes [ Time Frame: One year ] [ Designated as safety issue: No ]
- GLP-1 and GIP response curves [ Time Frame: One year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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. |
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. 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)
- Caucasians with type 2 diabetes mellitus according to WHO's criteria
- Patients fulfilling the criteria for laparoscopic gastric banding
- Normal Hemoglobin
- Informed consent
Inclusion Criteria: (controls)
- 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: (cases)
- Liver disease (ALAT > 2 x normal level)
- Diabetic nephropathy (s-creatinin > 130 µM or albuminuria)
- Diabetic neuropathy (anamnestic)
- Proliferative diabetic retinopathy (anamnestic)
- Medical treatment wich cannot be stopped for 12 hours
- Treatment with insulin, GLP-1 analogues or DPP-4 inhibitors
Exclusion Criteria: (controls)
- 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
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
No publications provided
| Responsible Party: | Katrine Bagge Hansen, MD, Glostrup Hospital |
| ClinicalTrials.gov Identifier: | NCT00625040 History of Changes |
| Other Study ID Numbers: | GB-INK |
| Study First Received: | February 19, 2008 |
| Last Updated: | March 7, 2008 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Keywords provided by Glostrup University Hospital, Copenhagen:
|
Incretin effect Gastric banding Glucagon Glucagon-Like Peptide 1 |
Gastric Inhibitory Peptide Glucose Intestinal Peptide Insulin C-peptide |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013