NCT00256256

Brief Summary

Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New animal studies indicate a protective effect of GLP-1 in the brain and the heart. The mechanism behind this is yet not known. The study hypothesis is that GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert its protective effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

October 30, 2007

Status Verified

October 1, 2007

First QC Date

November 16, 2005

Last Update Submit

October 29, 2007

Conditions

Type 2 DiabetesStrokeMyocardial Infarction

Keywords

type 2 diabetesGLP-1PETbrainheart

Outcome Measures

Primary Outcomes (1)

  • FDG-uptake in the brain and heart visualized by Positron emission tomography with and without GLP-1

    After 4 hours of GLP-infusion

Secondary Outcomes (1)

  • Laboratory values (insulin secretion and counter-regulatory hormones)

    During 7 hours of clamp and GLP-1/placebo infusion

Interventions

glucagon-like-peptide-1DRUG

Dose: 1.2pmol/kg/min for 6 hours

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy men
  • Age 20-50 years
  • Caucasian
  • BMI 20-30 kg/m2

You may not qualify if:

  • Diabetes in subject and 1.degree relatives
  • Any disease of clinical relevance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of pharmacology, Aarhus university

Aarhus, 8000, Denmark

Location

Related Publications (6)

  • During MJ, Cao L, Zuzga DS, Francis JS, Fitzsimons HL, Jiao X, Bland RJ, Klugmann M, Banks WA, Drucker DJ, Haile CN. Glucagon-like peptide-1 receptor is involved in learning and neuroprotection. Nat Med. 2003 Sep;9(9):1173-9. doi: 10.1038/nm919. Epub 2003 Aug 17.

    PMID: 12925848BACKGROUND

  • Nikolaidis LA, Mankad S, Sokos GG, Miske G, Shah A, Elahi D, Shannon RP. Effects of glucagon-like peptide-1 in patients with acute myocardial infarction and left ventricular dysfunction after successful reperfusion. Circulation. 2004 Mar 2;109(8):962-5. doi: 10.1161/01.CIR.0000120505.91348.58. Epub 2004 Feb 23.

    PMID: 14981009BACKGROUND

  • Holst JJ. On the physiology of GIP and GLP-1. Horm Metab Res. 2004 Nov-Dec;36(11-12):747-54. doi: 10.1055/s-2004-826158.

    PMID: 15655703BACKGROUND

  • Perry T, Haughey NJ, Mattson MP, Egan JM, Greig NH. Protection and reversal of excitotoxic neuronal damage by glucagon-like peptide-1 and exendin-4. J Pharmacol Exp Ther. 2002 Sep;302(3):881-8. doi: 10.1124/jpet.102.037481.

    PMID: 12183643BACKGROUND

  • Bose AK, Mocanu MM, Carr RD, Yellon DM. Glucagon like peptide-1 is protective against myocardial ischemia/reperfusion injury when given either as a preconditioning mimetic or at reperfusion in an isolated rat heart model. Cardiovasc Drugs Ther. 2005 Jan;19(1):9-11. doi: 10.1007/s10557-005-6892-4. No abstract available.

    PMID: 15883751BACKGROUND

  • Gejl M, Lerche S, Mengel A, Moller N, Bibby BM, Smidt K, Brock B, Sondergaard H, Botker HE, Gjedde A, Holst JJ, Hansen SB, Rungby J. Influence of GLP-1 on myocardial glucose metabolism in healthy men during normo- or hypoglycemia. PLoS One. 2014 Jan 6;9(1):e83758. doi: 10.1371/journal.pone.0083758. eCollection 2014.

    PMID: 24400077DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2StrokeMyocardial Infarction

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Ole Schmitz, MD,professor

    Department of pharmacology, Aarhus university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2005

First Posted

November 21, 2005

Study Start

November 1, 2005

Study Completion

January 1, 2007

Last Updated

October 30, 2007

Record last verified: 2007-10

Locations

DK(1)