Incretin Hormones in Type-1 Diabetes Mellitus Glycemic Response in Type-1 Diabetes Mellitus
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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 |
| Study Type: | Observational |
| Official Title: | Secretion and Significance of the Incretin Hormones on the Postprandial Glycemic Response in Type-1 Diabetes Mellitus |
- blood glucose [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- 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
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) |
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 |
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
Contacts and Locations| Denmark | |
| Hvidovre University Hospital | |
| Hvidovre, Denmark, 2650 | |
| Study Director: | Urd Kielgast, MD | unafilliated |
| Principal Investigator: | Sten Madsbad, MD, DMSc | Unafilliated |
More Information
No publications provided
| Responsible Party: | Urd Kielgast, MD, Hvidovre University Hospital |
| ClinicalTrials.gov Identifier: | NCT00832741 History of Changes |
| Other Study ID Numbers: | H-C-2007-0080, 2008-41-1811 |
| Study First Received: | January 29, 2009 |
| Last Updated: | January 29, 2009 |
| Health Authority: | Denmark: Danish Dataprotection Agency Denmark: Ethics Committee |
Keywords provided by Hvidovre University Hospital:
|
GLP-1 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 Hormones Incretins Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013