GIP and GLP-1 in Type 1 Diabetes

This study has been completed.
University of Copenhagen
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen Identifier:
First received: November 17, 2012
Last updated: July 10, 2015
Last verified: July 2015
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.

Condition Intervention
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 ]

Enrollment: 10
Study Start Date: July 2012
Study Completion Date: November 2013
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


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

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
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Please refer to this study by its identifier: NCT01739283

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

No publications provided by University Hospital, Gentofte, Copenhagen

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mikkel Christensen, principal investigator, University Hospital, Gentofte, Copenhagen Identifier: NCT01739283     History of Changes
Other Study ID Numbers: H-2-2009-078 33269
Study First Received: November 17, 2012
Last Updated: July 10, 2015
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Glucose Metabolism Disorders
Metabolic Diseases processed this record on November 27, 2015