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CompletedNCT01739283Updated Jul 13, 2015

GIP and GLP-1 in Type 1 Diabetes

An interventional study of GIP and GLP-1 in Hypoglycemia, sponsored by Mikkel Christensen. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-07-13.

Sponsored by Mikkel Christensen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Hypoglycemia

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03

In context

Hypoglycemia

654 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

This study's enrollment of 10 is below the median of 29 across 479 interventional studies indexed under Hypoglycemia.

Browse Hypoglycemia studies →

Lead sponsor

Mikkel Christensen is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosed with type 1 diabetes (WHO criteria)

Exclusion 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    hyperglycemia

    Hyperglycemic clamping

    Other: GIP · Other: Saline

  • Experimental
    hypoglycemia

    Hypoglycemic clamping

    Other: GIP · Other: GLP-1 · Other: Saline

Interventions

  • OtherGIP
  • OtherGLP-1
  • OtherSaline
06

What researchers measure

Primary outcomes

  1. plasma glucagon area under curve values

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

Secondary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Gentofte Hospital
    Hellerup, 2900, Denmark
08

References and documents

Publications

  • Christensen M, Calanna S, Sparre-Ulrich AH, Kristensen PL, Rosenkilde MM, Faber J, Purrello F, van Hall G, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide augments glucagon responses to hypoglycemia in type 1 diabetes. Diabetes. 2015 Jan;64(1):72-8. doi: 10.2337/db14-0440. Epub 2014 Jul 22. PubMed 25053587 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01739283
Lead sponsor
Mikkel Christensen
Collaborators
University of Copenhagen
Responsible party
Mikkel Christensen (principal investigator, University Hospital, Gentofte, Copenhagen) — Sponsor-investigator
First posted
Dec 3, 2012
Start date
Jul 2012
Primary completion
Apr 2013
Completion
Nov 2013
Last update
Jul 13, 2015

Study contacts

Mikkel Christensen, MD
principal investigator · University Hospital, Gentofte, Copenhagen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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