GIP and GLP-1 in Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital, Gentofte, Copenhagen
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01739283
First received: November 17, 2012
Last updated: March 31, 2013
Last verified: March 2013
  Purpose

Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.


Condition Intervention
Hypoglycemia
Other: GIP
Other: GLP-1
Other: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Resource links provided by NLM:


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

Primary Outcome Measures:
  • plasma glucagon area under curve values [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • plasma gut hormones and nutrients (absolute, incremental and area under curve values) [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Glucose and glycerol tracer kinetics [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ] [ Designated as safety issue: No ]
  • glucose (g/kg body weight) needed to be infuse to keep clamp [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hyperglycemia
Hyperglycemic clamping
Other: GIP Other: Saline
Experimental: hypoglycemia
Hypoglycemic clamping
Other: GIP Other: GLP-1 Other: Saline

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Diagnosed with type 1 diabetes (WHO criteria)

Exclusion Criteria:

  • HbA1c > 9 %
  • Liver disease (ALAT/ASAT > 2 x upper normal limit)
  • Diabetic nephropathy (s-creatinine > 130 µM or albuminuria)
  • Proliferative diabetic retinopathy (anamnestic)
  • Severe arteriosclerosis or heart failure (NYHA group III or IV)
  • Anemia
  • treatment with medication not applicable to pause for 12 hours
  • C-peptide increase after 50 g iv arginine
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739283

Contacts
Contact: Mikkel Christensen, Christensen +45 39773320

Locations
Denmark
Gentofte Hospital Recruiting
Hellerup, Denmark, 2900
Contact: Mikkel Christensen, MD         
Sponsors and Collaborators
Mikkel Christensen
University of Copenhagen
Investigators
Principal Investigator: Mikkel Christensen, MD Copenhagen University Hospital Gentofte
  More Information

No publications provided

Responsible Party: Mikkel Christensen, principal investigator, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01739283     History of Changes
Other Study ID Numbers: H-2-2009-078 33269
Study First Received: November 17, 2012
Last Updated: March 31, 2013
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014