Beta-Cell Function After Near-Normalisation of Blood Glucose - Full Text View

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00612950

Purpose

The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.

Condition	Intervention
Type 2 Diabetes	Drug: glucagon-like peptide-1, Drug: glucose dependent insulinotropic polypeptide Drug: Saline

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose Glucagon Glucagon-like peptide 1

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

2.phase insulin response measured as incremental area under the curve from 10-120 minutes [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Enrollment:	8
Study Start Date:	October 2006
Study Completion Date:	May 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GLP-1: Experimental	Drug: glucagon-like peptide-1, GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
GIP: Experimental	Drug: glucose dependent insulinotropic polypeptide continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
saline: Placebo Comparator	Drug: Saline continuous infusion of Saline for 120 min

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-70 years
Type 2 diabetes diagnosed after 30 years of age
BMI > 25

Exclusion Criteria:

Severe complications to diabetes
Abnormal liver and kidney function
Haemoglobin below the lower limit
Macroalbuminuria
Systemic disease
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612950

Locations

Denmark
Dept. of Endocrinology, Hvidovre Hospital
Copenhagen, Denmark

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Principal Investigator:

Patricia V Højberg, MD, PHD

University Hospital Hvidovre

More Information

No publications provided by Hvidovre University Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Højberg PV, Vilsbøll T, Rabøl R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. Epub 2008 Nov 27.

Responsible Party:	Kettegaard Alle 30, 2650 Hvidovre ( Patricia Verdugo Højberg/ MD, PHD )
Study ID Numbers:	KA 03005, KA 03005
Study First Received:	January 16, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00612950 History of Changes
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Metabolic Diseases
Gastric Inhibitory Polypeptide
Hormone Antagonists
Glucagon
Hormones, Hormone Substitutes, and Hormone Antagonists
Diabetes Mellitus
Endocrine System Diseases
Hormones

Insulin
Glucagon-Like Peptide 1
Diabetes Mellitus, Type 2
Incretins
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Metabolic Diseases
Gastric Inhibitory Polypeptide
Physiological Effects of Drugs
Diabetes Mellitus
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Endocrine System Diseases

Hormones
Pharmacologic Actions
Glucagon-Like Peptide 1
Therapeutic Uses
Diabetes Mellitus, Type 2
Incretins
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009