Clinical trial NCT00832741: 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
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Keywords: GLP-1
Type 1 diabetes
Glycemic control
Incretin hormone
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2009-01-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic patients and community population(control subjects)

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.

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

Primary outcomes:
measure: blood glucose
timeFrame: 4 hours
Secondary outcomes:
measure: GLP-1 and GIP response during a meal
timeFrame: 4 hours
measure: betacell function (incremental area under the c-peptide concentration curve)
timeFrame: 4 hours
measure: alfa cell function (plasma glucagon)
timeFrame: 4 hours
measure: gastric emptying
timeFrame: 4 hours
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: unafilliated
name: Urd Kielgast, MD
role: STUDY_DIRECTOR
affiliation: Unafilliated
name: Sten Madsbad, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: