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

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00603031
First received: January 15, 2008
Last updated: January 20, 2011
Last verified: August 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus

Resource links provided by NLM:

Drug Information available for: Glucagon
U.S. FDA Resources

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 ]

Enrollment: 9
Study Start Date: January 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLP-1
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
Placebo Comparator: NaCl
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
Experimental: GIP
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

Locations
Denmark
Dept. of Endocrinology, Hvidovre Hospital
Copenhagen, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Urd Kielgast, MD unafilliated
  More Information

No publications provided

Responsible Party: Urd Kielgast,MD, Urd Kielgast, MD
ClinicalTrials.gov Identifier: NCT00603031     History of Changes
Other Study ID Numbers: H-D-2007-0076, 2008-000305-11
Study First Received: January 15, 2008
Last Updated: January 20, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Gastric Inhibitory Polypeptide
Glucagon-Like Peptide 1
 Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013