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Clinical Trials/NCT01739283
NCT01739283CompletedNot Applicable

GIP and GLP-1 in Type 1 Diabetes

Mikkel Christensen2 sites in 1 country10 target enrollmentStarted: July 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
2
Primary Endpoint
plasma glucagon area under curve values

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
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)
  • treatment with medication not applicable to pause for 12 hours
  • C-peptide increase after 50 g iv arginine

Arms & Interventions

hypoglycemia

Experimental

Hypoglycemic clamping

Intervention: GLP-1 (Other)

Outcomes

Primary Outcomes

plasma glucagon area under curve values

Time Frame: approx. 15 minutes intervals, time 0 to 120 min

Secondary Outcomes

  • plasma gut hormones and nutrients (absolute, incremental and area under curve values)(approx. 15 minutes intervals, time 0 to 120 min)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mikkel Christensen

principal investigator

University Hospital, Gentofte, Copenhagen

Study Sites (2)

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