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Beta-Cell Function After Near-Normalisation of Blood Glucose

Primary Purpose

Type 2 Diabetes

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

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 18-70 years
  • Type 2 diabetes diagnosed after 30 years of age
  • BMI > 25

Exclusion Criteria:

  • Severe complications to diabetes
  • Abnormal liver and 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

Experimental

Placebo Comparator

Arm Label

GLP-1

GIP

saline

Arm Description

Outcomes

Primary Outcome Measures

2.phase insulin response measured as incremental area under the curve from 10-120 minutes

Secondary Outcome Measures

2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment

Full Information

First Posted
January 16, 2008
Last Updated
February 11, 2008
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00612950
Brief Title
Beta-Cell Function After Near-Normalisation of Blood Glucose
Official Title
Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GLP-1
Arm Type
Experimental
Arm Title
GIP
Arm Type
Experimental
Arm Title
saline
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
glucagon-like peptide-1,
Intervention Description
GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
Intervention Type
Drug
Intervention Name(s)
glucose dependent insulinotropic polypeptide
Intervention Description
continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
continuous infusion of Saline for 120 min
Primary Outcome Measure Information:
Title
2.phase insulin response measured as incremental area under the curve from 10-120 minutes
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18-70 years Type 2 diabetes diagnosed after 30 years of age BMI > 25 Exclusion Criteria: Severe complications to diabetes Abnormal liver and kidney function Haemoglobin below the lower limit Macroalbuminuria Systemic disease Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia V Højberg, MD, PHD
Organizational Affiliation
University Hospital Hvidovre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Endocrinology, Hvidovre Hospital
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
19037628
Citation
Hojberg PV, Vilsboll T, Rabol R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.
Results Reference
derived

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Beta-Cell Function After Near-Normalisation of Blood Glucose

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