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Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

Primary Purpose

Type-1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
glucagon like peptide -1
NaCl
glucose dependent insulinotropic polypeptide
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type-1 Diabetes Mellitus

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-60 years
  • Type-1 diabetes diagnosed between 5-40 years of age
  • Normal weight(BMI 18-27),
  • Insulin treatment from time of diagnosis.

Exclusion Criteria:

  • Severe complications to diabetes
  • Abnormal liver or kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy.

Sites / Locations

  • Dept. of Endocrinology, Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

GLP-1

NaCl

GIP

Arm Description

time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).

Outcomes

Primary Outcome Measures

phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose

Secondary Outcome Measures

maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)

Full Information

First Posted
January 15, 2008
Last Updated
January 20, 2011
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00603031
Brief Title
Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus
Official Title
Effect of GLP-1 and GIP on the Maximal Insulin Secretory Capacity in Type-1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
study hypothesis: treatment with GLP-1 and/or GIP is able to potentiate the maximal stimulated insulin secretion even in c-peptide negative type-1 diabetic patients classified as having no residual beta cell function left.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type-1 Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLP-1
Arm Type
Experimental
Arm Description
time -30-90 min: Continuous infusion with GLP-1 (1,2pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).
Arm Title
NaCl
Arm Type
Placebo Comparator
Arm Description
time -30-90 min: Continuous infusion with NaCl time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).
Arm Title
GIP
Arm Type
Experimental
Arm Description
time -30-90 min: Continuous infusion with GIP-1 (3,6pmol/kg/min) time 0-90 min:hyperglycemic clamp(20mmol/L) time 45 min:infusion of L-Arginine (5g).
Intervention Type
Other
Intervention Name(s)
glucagon like peptide -1
Intervention Description
continuous infusion 1,2 pmol pr. kg pr minute at 120 minutes
Intervention Type
Other
Intervention Name(s)
NaCl
Intervention Description
infusion with NaCl for 120 minutes as placebo-arm
Intervention Type
Other
Intervention Name(s)
glucose dependent insulinotropic polypeptide
Intervention Description
continuous infusion with GIP-1 (3,6pmol/kg/min) at 120 minutes.
Primary Outcome Measure Information:
Title
phase insulin response and phase insulin response measured as incremental area under the curve from 0-10 minutes and incremental area under the curve from 10-45 minutes respectively after iv glucose
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
maximal insulin response defined as mean insulin at time 47 and 49 minutes (2 and 4 minutes after infusion of L-Arginine)
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-60 years Type-1 diabetes diagnosed between 5-40 years of age Normal weight(BMI 18-27), Insulin treatment from time of diagnosis. Exclusion Criteria: Severe complications to diabetes Abnormal liver or kidney function Haemoglobin below the lower limit Macroalbuminuria Systemic disease Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urd Kielgast, MD
Organizational Affiliation
unafilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Endocrinology, Hvidovre Hospital
City
Copenhagen
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Effect of GLP-1 and GIP on Insulin Secretion in Type-1 Diabetes Mellitus

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