The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes - Full Text View

The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes

This study is currently recruiting participants.
Verified by University Hospital, Gentofte, Copenhagen, December 2006

Sponsored by:	University Hospital, Gentofte, Copenhagen
Information provided by:	University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:	NCT00321321

Purpose

We hypothesize that the impaired insulinotropic effect of the incretin hormone GIP may be due to inadequate sensitization and ATP induced closure of beta cell K-ATP channels. By closing the channels through the use of SU we hope to restore the insulinotropic effect of GIP.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: Sulfonylurea	Phase II

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Official Title:	Phase 2 Study of The Beta Cell Responsiveness to GIP With and Without Sulfonylurea in Patients With Type 2 Diabetes

Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:

Insulin secretion

Estimated Enrollment:	8
Study Start Date:	May 2006
Estimated Study Completion Date:	August 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 diabetes mellitus diagnosed according to WHO criteria
diet and/or metformin treatment
HbA1c > 7,0% for metformin treated patients
HbA1c > 7,5% for diet treated patients
age: 18 years or older
25 > BMI > 40 kg/m2
signed informed consent
Sufficient birth control in case of child bearing capacity

Exclusion Criteria:

Proliferative retinopathy
Diabetic nephropathy with s-creatinin > 130 microM and/or macroalbuminuria
Liver disease (ALAT > 2 x normal value)
CAD (NYHA group III or IV)
Positive screening for islet-cell and/or GAD-65 autoantibodies
Type 1 diabetes i first degree relatives
gastrointestinal surgery with intestinal resection
Anemia
Pregnancy and/or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321321

Contacts


Contact: Kasper Aaboe, M.D.	+45 39978474	kasper@dadlnet.dk

Locations


Denmark
	Department of Internal Medicine, Gentofte University Hospital	Recruiting
	Hellerup, Copenhagen, Denmark, 2900
	Principal Investigator: Kasper Aaboe, M.D.

Sponsors and Collaborators

University Hospital, Gentofte, Copenhagen

Investigators


Principal Investigator:	Kasper Aaboe, M.D.	Gentofte University Hospital

More Information

Study ID Numbers:	KA-05011
First Received:	May 2, 2006
Last Updated:	December 22, 2006
ClinicalTrials.gov Identifier:	NCT00321321
Health Authority:	Denmark: Ethics Committee

Keywords provided by University Hospital, Gentofte, Copenhagen:

Type 2 diabetes mellitus

Glucose dependent insulinotropic polypeptide

Sulfonylurea compounds

insulin secretion

Sulfonylurea receptor subunit-SUR1

Impaired incretin effect

Study placed in the following topic categories:

Gastric Inhibitory Polypeptide

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Therapeutic Uses

Physiological Effects of Drugs

Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists

Incretins

Hormones

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008