Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus - Full Text View

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00603031

Purpose

study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

Condition	Intervention
Type-1 Diabetes Mellitus	Other: glucagon like peptide -1 Other: NaCl Other: glucose dependent insulinotropic polypeptide

MedlinePlus related topics: Diabetes Diabetes Type 1

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine) [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GLP-1: Experimental time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).	Other: glucagon like peptide -1 continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes
NaCl: Placebo Comparator time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).	Other: NaCl infusion with NaCl for 120 minutes as placebo-arm
GIP: Experimental time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).	Other: glucose dependent insulinotropic polypeptide continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age 18-60 years
Type-1 diabetes diagnosed between 5-40 years of age
Normal weight(BMI 18-27),
Insulin treatment from time of diagnosis.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603031

Contacts

Contact: Urd Kielgast, MD	+453632-3389	urd.kielgast@hvh.regionh.dk
Contact: Sten Masdsbad, MD, DMSC, Chief physisian	+45 3632-2291	sten.madsbad@hvh.regionh.dk

Locations

Denmark
Dept. of Endocrinology, Hvidovre Hospital	Recruiting
Copenhagen, Denmark, 2650
Contact: Urd Kielgast, MD +453632-3389 urd.kielgast@hvh.regionh.dk
Contact: Sten Madsbad, MD, DMCS, Chief Physisian. +453632-2291 sten.masbad@hvh.regionh.dk
Principal Investigator: Urd Kielgast, MD

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Principal Investigator:

Urd Kielgast, MD

unafilliated

More Information

Responsible Party:	Urd Kielgast, MD ( Urd Kielgast,MD )
Study ID Numbers:	H-D-2007-0076, 2008-000305-11
Study First Received:	January 15, 2008
Last Updated:	January 26, 2008
ClinicalTrials.gov Identifier:	NCT00603031
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee

Study placed in the following topic categories:

Gastric Inhibitory Polypeptide
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glucagon
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin
Glucagon-Like Peptide 1

Additional relevant MeSH terms:

Immune System Diseases
Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents

Hormones, Hormone Substitutes, and Hormone Antagonists
Incretins
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009