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GIP and GLP-1 in Type 1 Diabetes

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.
ClinicalTrials.gov Identifier: NCT01739283
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : July 13, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Hypoglycemia Other: GIP Other: GLP-1 Other: Saline

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Study Start Date : July 2012
Primary Completion Date : April 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: hyperglycemia
Hyperglycemic clamping
Other: GIP Other: Saline
Experimental: hypoglycemia
Hypoglycemic clamping
Other: GIP Other: GLP-1 Other: Saline


Outcome Measures

Primary Outcome Measures :
  1. plasma glucagon area under curve values [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ]

Secondary Outcome Measures :
  1. plasma gut hormones and nutrients (absolute, incremental and area under curve values) [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ]

Other Outcome Measures:
  1. Glucose and glycerol tracer kinetics [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ]
  2. glucose (g/kg body weight) needed to be infuse to keep clamp [ Time Frame: approx. 15 minutes intervals, time 0 to 120 min ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

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): NCT01739283


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: July 13, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases