Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus - Full Text View

Sponsored by:	Hvidovre University Hospital
Information provided by:	Hvidovre University Hospital
ClinicalTrials.gov Identifier:	NCT00832741

Purpose

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
Type 1 Diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

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

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:

blood glucose [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GLP-1 and GIP response during a meal [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
betacell function (incremental area under the c-peptide concentration curve) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
alfa cell function (plasma glucagon) [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
gastric emptying [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

primary care clinic patients and community population(control subjects)

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00832741

Locations

Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650

Sponsors and Collaborators

Hvidovre University Hospital

Investigators

Study Director:	Urd Kielgast, MD	unafilliated
Principal Investigator:	Sten Madsbad, MD, DMSc	Unafilliated

More Information

No publications provided

Responsible Party:	Hvidovre University Hospital ( Urd Kielgast, MD )
Study ID Numbers:	H-C-2007-0080, 2008-41-1811
Study First Received:	January 29, 2009
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00832741 History of Changes
Health Authority:	Denmark: Danish Dataprotection Agency; Denmark: Ethics Committee

Keywords provided by Hvidovre University Hospital:

GLP-1
Type 1 diabetes
Glycemic control
Incretin hormone

Study placed in the following topic categories:

Metabolic Diseases
Autoimmune Diseases
Hormone Antagonists
Diabetes Mellitus
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Diabetes Mellitus Type 1

Hormones
Glucagon-Like Peptide 1
Diabetes Mellitus, Type 1
Incretins
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Incretins
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009