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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

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.

Condition or disease
Type 1 Diabetes

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.

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Study Type : Observational
Actual Enrollment : 30 participants
Official Title: Secretion and Significance of the Incretin Hormones on the Postprandial Glycemic Response in Type-1 Diabetes Mellitus
Study Start Date : May 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. blood glucose [ Time Frame: 4 hours ]

Secondary Outcome Measures :
  1. GLP-1 and GIP response during a meal [ Time Frame: 4 hours ]
  2. betacell function (incremental area under the c-peptide concentration curve) [ Time Frame: 4 hours ]
  3. alfa cell function (plasma glucagon) [ Time Frame: 4 hours ]
  4. gastric emptying [ Time Frame: 4 hours ]

Biospecimen Retention:   Samples With DNA
whole blood, plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic patients and community population(control subjects)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00832741

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Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
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Study Director: Urd Kielgast, MD unafilliated
Principal Investigator: Sten Madsbad, MD, DMSc Unafilliated

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Responsible Party: Urd Kielgast, MD, Hvidovre University Hospital Identifier: NCT00832741     History of Changes
Other Study ID Numbers: H-C-2007-0080
First Posted: January 30, 2009    Key Record Dates
Last Update Posted: January 30, 2009
Last Verified: January 2009
Keywords provided by Hvidovre University Hospital:
Type 1 diabetes
Glycemic control
Incretin hormone
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Gastric Inhibitory Polypeptide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Gastrointestinal Agents