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GIP and GLP-1 in Type 1 Diabetes

Primary Purpose

Hypoglycemia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GIP
GLP-1
Saline
Sponsored by
Mikkel Christensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoglycemia

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

hyperglycemia

hypoglycemia

Arm Description

Hyperglycemic clamping

Hypoglycemic clamping

Outcomes

Primary Outcome Measures

plasma glucagon area under curve values

Secondary Outcome Measures

plasma gut hormones and nutrients (absolute, incremental and area under curve values)

Full Information

First Posted
November 17, 2012
Last Updated
July 10, 2015
Sponsor
Mikkel Christensen
Collaborators
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01739283
Brief Title
GIP and GLP-1 in Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mikkel Christensen
Collaborators
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hyperglycemia
Arm Type
Experimental
Arm Description
Hyperglycemic clamping
Arm Title
hypoglycemia
Arm Type
Experimental
Arm Description
Hypoglycemic clamping
Intervention Type
Other
Intervention Name(s)
GIP
Intervention Type
Other
Intervention Name(s)
GLP-1
Intervention Type
Other
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
plasma glucagon area under curve values
Time Frame
approx. 15 minutes intervals, time 0 to 120 min
Secondary Outcome Measure Information:
Title
plasma gut hormones and nutrients (absolute, incremental and area under curve values)
Time Frame
approx. 15 minutes intervals, time 0 to 120 min
Other Pre-specified Outcome Measures:
Title
Glucose and glycerol tracer kinetics
Time Frame
approx. 15 minutes intervals, time 0 to 120 min
Title
glucose (g/kg body weight) needed to be infuse to keep clamp
Time Frame
approx. 15 minutes intervals, time 0 to 120 min

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel Christensen, MD
Organizational Affiliation
Copenhagen University Hospital, Gentofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25053587
Citation
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.
Results Reference
derived

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GIP and GLP-1 in Type 1 Diabetes

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