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

This study has been completed.
Information provided by:
Hvidovre University Hospital Identifier:
First received: January 29, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
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.

Type 1 Diabetes

Study Type: Observational
Official Title: Secretion and Significance of the Incretin Hormones on the Postprandial Glycemic Response in Type-1 Diabetes Mellitus

Resource links provided by NLM:

Further study details as provided by Hvidovre University Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
whole blood, plasma

Enrollment: 30
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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.

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
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Please refer to this study by its identifier: NCT00832741

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

Responsible Party: Urd Kielgast, MD, Hvidovre University Hospital Identifier: NCT00832741     History of Changes
Other Study ID Numbers: H-C-2007-0080
Study First Received: January 29, 2009
Last Updated: January 29, 2009

Keywords provided by Hvidovre University Hospital:
Type 1 diabetes
Glycemic control
Incretin hormone

Additional relevant MeSH terms:
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 processed this record on September 21, 2017