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

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT00832741
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-01
• Study First Submitted: 2009-01-29
• Study First Submitted QC: 2009-01-29
• Last Update Submitted: 2009-01-29
• Study First Posted: 2009-01-30
• Last Update Posted: 2009-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
blood glucose	4 hours

Secondary Outcome Measures

Name	Time	Method
alfa cell function (plasma glucagon)	4 hours
gastric emptying	4 hours
GLP-1 and GIP response during a meal	4 hours
betacell function (incremental area under the c-peptide concentration curve)	4 hours

Trial Locations

Locations (1)

Hvidovre University Hospital; 🇩🇰 Hvidovre, Denmark