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GIP and GLP-1 in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT01739283
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : July 13, 2015
University of Copenhagen
Information provided by (Responsible Party):
Mikkel Christensen, University Hospital, Gentofte, Copenhagen

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

Condition or disease Intervention/treatment Phase
Hypoglycemia Other: GIP Other: GLP-1 Other: Saline Not Applicable

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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
Actual Primary Completion Date : April 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

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

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 ]

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

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

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Gentofte Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
Mikkel Christensen
University of Copenhagen
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Principal Investigator: Mikkel Christensen, MD Copenhagen University Hospital, Gentofte
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mikkel Christensen, principal investigator, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01739283    
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:
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Glucose Metabolism Disorders
Metabolic Diseases