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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00832741
Recruitment Status : Completed
First Posted : January 30, 2009
Last Update Posted : January 30, 2009
Information provided by:
Hvidovre University Hospital

January 29, 2009
January 30, 2009
January 30, 2009
May 2008
October 2008   (Final data collection date for primary outcome measure)
blood glucose [ Time Frame: 4 hours ]
Same as current
No Changes Posted
  • GLP-1 and GIP response during a meal [ Time Frame: 4 hours ]
  • betacell function (incremental area under the c-peptide concentration curve) [ Time Frame: 4 hours ]
  • alfa cell function (plasma glucagon) [ Time Frame: 4 hours ]
  • gastric emptying [ Time Frame: 4 hours ]
Same as current
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Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus
Secretion and Significance of the Incretin Hormones on the Postprandial Glycemic Response in Type-1 Diabetes Mellitus
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.
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.
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Retention:   Samples With DNA
whole blood, plasma
Non-Probability Sample
primary care clinic patients and community population(control subjects)
Type 1 Diabetes
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2008
October 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Urd Kielgast, MD, Hvidovre University Hospital
Hvidovre University Hospital
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Study Director: Urd Kielgast, MD unafilliated
Principal Investigator: Sten Madsbad, MD, DMSc Unafilliated
Hvidovre University Hospital
January 2009