We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00603031
First Posted: January 28, 2008
Last Update Posted: January 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hvidovre University Hospital
  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
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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:


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 ]

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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: Ethical Comitee, Copenhagen, Denmark )
First Submitted: January 15, 2008
First Posted: January 28, 2008
Last Update Posted: January 21, 2011
Last Verified: August 2009

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