|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00285896 |
|
Date of registration:
|
01/02/2006 |
|
Primary sponsor: |
|
|
Public title:
|
GLP-1 Infusion and Long-Time Fasting
|
|
Scientific title:
|
The Effect of 48 Hours of GLP-1 Infusion During Long-Time Fasting on Glycaemia and Counterregulatory Hormones |
|
Date of first enrolment:
|
December 2005 |
|
Target sample size:
|
8 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00285896 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Contacts
|
|
Name:
|
Birgitte Brock, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of Pharmacology ,University of Aarhus |
|
|
Name:
|
Ole E. Schmitz, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Department of pharmacology, Aarhus university |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- healthy male, age 20-50 years, BMI 20-30 kg/m2, Blood pressure < 140/90 mmHg, caucasian.
Exclusion Criteria:
- Diabetes in relatives, anaemia, any significant disease, smoking.
Age minimum:
20 Years
Age maximum:
50 Years
Gender:
Male
|
|
Health Condition(s) or Problem(s) studied
|
|
Type 2 Diabetes
|
|
Intervention(s)
|
|
Drug: Glucagon-like-peptide-1 (7-36) amide
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Area under curve (AUC)for plasma glucose, insulin, insulin secretion velocity and glucagon for the periods 0-48 hours(day 1-2) and 0-180 min (day 3). And also the lowest plasma glucose during the period 0-180 min day 3 and mean blood pressure
[Time Frame: measured every 4 hours for 48 hours (day 1-2) and every 15-30 minutes(day 3)]
|
|
Secondary ID(s)
|
|
2004-0172
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|