GIP and GLP-1 in Type 1 Diabetes

Sponsors

Lead Sponsor: Mikkel Christensen

Collaborator: University of Copenhagen

Source University Hospital, Gentofte, Copenhagen
Brief Summary

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

Overall Status Completed
Start Date July 2012
Completion Date November 2013
Primary Completion Date April 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
plasma glucagon area under curve values approx. 15 minutes intervals, time 0 to 120 min
Secondary Outcome
Measure Time Frame
plasma gut hormones and nutrients (absolute, incremental and area under curve values) approx. 15 minutes intervals, time 0 to 120 min
Enrollment 10
Condition
Intervention

Intervention Type: Other

Intervention Name: GIP

Intervention Type: Other

Intervention Name: GLP-1

Arm Group Label: hypoglycemia

Intervention Type: Other

Intervention Name: Saline

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

Gender: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mikkel Christensen, MD Principal Investigator Copenhagen University Hospital, Gentofte
Location
Facility: Gentofte Hospital
Location Countries

Denmark

Verification Date

July 2015

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University Hospital, Gentofte, Copenhagen

Investigator Full Name: Mikkel Christensen

Investigator Title: principal investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: hyperglycemia

Type: Experimental

Description: Hyperglycemic clamping

Label: hypoglycemia

Type: Experimental

Description: Hypoglycemic clamping

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov