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Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Locations
Denmark
Study Type
Observational
Intervention
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Type 1 Diabetes focused on measuring GLP-1, Type 1 diabetes, Glycemic control, Incretin hormone

Eligibility Criteria

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

Inclusion Criteria:

  • type-1 diabetes mellitus
  • diagnosis between 5-40 years.
  • age 18-60 year
  • normal weight at time of diagnosis
  • insulintreatment from diagnosis
  • HbA1c < 7.6 %

Exclusion Criteria:

  • diabetic complications
  • disease other than type-1 diabetes

Sites / Locations

  • Hvidovre University Hospital

Outcomes

Primary Outcome Measures

blood glucose

Secondary Outcome Measures

GLP-1 and GIP response during a meal
betacell function (incremental area under the c-peptide concentration curve)
alfa cell function (plasma glucagon)
gastric emptying

Full Information

First Posted
January 29, 2009
Last Updated
January 29, 2009
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00832741
Brief Title
Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus
Official Title
Secretion and Significance of the Incretin Hormones on the Postprandial Glycemic Response in Type-1 Diabetes Mellitus
Study Type
Observational

2. Study Status

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

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate whether secretion of incretin hormones is intact and to what extent endogenous as well as exogenous GLP-1 controls postprandial glucose excursions in patients with type-1 diabetes mellitus.
Detailed Description
GLP-1 and GIP are incretin hormones secreted from specific endocrine celles in the gut. Stimulus for secretion is prescence of carbohydrates, fat and protein in the gut. The incretin hormones controls postprandial glucose excursions through stimulation of insulinsecretion as well as inhibition of glucagon and gastric emptying.The effects of GLP-1 on insulin secretion and glucagon inhibition are glucose dependent and the risc of hypoglycemia is therefore negligible when the hormone is administered in supra physiological concentrations.Furthermore, some animal studies suggest that GLP-1 has a trofic effect on the betacells and the hormone has been shown to replenish intracellular stores of insulin. Because the main bloodglucose lowering effect of GLP-1 has been thought to be due to increased insulin secretion, analouges of the hormone has been developed for the treatment of type-2 diabetes. So far, relatively little is known about the effect of GLP-1 in type-1 diabetes.It possible, that GLP-1 in combination with insulin (possibly mainly through its effect on glucagon inhibition and gastric emptying) could reduce the need for exogenous insulin with a concomitant reduced risc of hypoglycemia. Without compromising the target glucemic control. This study focuses of the postprandial bloodglucose lowering effects of endogenous as well as exogenous GLP-1 in patients with type-1 diabetes according to residual betacell function and glycemic control.Furthermore, the endogenous secretion of incretin hormones in patients with type-1 diabetes mellitus will be compared to that of matched normal controls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
GLP-1, Type 1 diabetes, Glycemic control, Incretin hormone

7. Study Design

Enrollment
30 (Actual)
Biospecimen Retention
Samples With DNA
Biospecimen Description
whole blood, plasma
Primary Outcome Measure Information:
Title
blood glucose
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
GLP-1 and GIP response during a meal
Time Frame
4 hours
Title
betacell function (incremental area under the c-peptide concentration curve)
Time Frame
4 hours
Title
alfa cell function (plasma glucagon)
Time Frame
4 hours
Title
gastric emptying
Time Frame
4 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: type-1 diabetes mellitus diagnosis between 5-40 years. age 18-60 year normal weight at time of diagnosis insulintreatment from diagnosis HbA1c < 7.6 % Exclusion Criteria: diabetic complications disease other than type-1 diabetes
Study Population Description
primary care clinic patients and community population(control subjects)
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urd Kielgast, MD
Organizational Affiliation
unafilliated
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sten Madsbad, MD, DMSc
Organizational Affiliation
Unafilliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hvidovre University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus

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