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The effect of dopamine depletion on endogenous glucose production in healthy subjects.


- candidate number6437
- NTR NumberNTR1999
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2009
- Secondary IDsMEC 08/347 METC Academic medical center
- Public TitleThe effect of dopamine depletion on endogenous glucose production in healthy subjects.
- Scientific TitleThe effect of dopamine depletion on endogenous glucose production in healthy subjects.
- ACRONYMCLAMPT study
- hypothesisHepatic insulin sensitivity increase after dopamine depletion, with a-methylparatyrosine (AMPT).
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Insulin resistance
- Inclusion criteria1. Healthy men;
2. Age: 18-35 years;
3. BMI: 20-25 kg/m2.
- Exclusion criteria1. DM type I and II or any other chronic disease;
2. Renal insufficiency or elevated liver enzymes;
3. Family history of DMII;
4. Primary dyslipidemia;
5. Use of any drugs and history of drug abuse;
6. Alcohol consumption >3/day;
7. Performance of vigorous exercise;
8. History of psychiatric disorders.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 10-jan-2009
- planned closingdate6-jan-2010
- Target number of participants10
- InterventionsEach subject will be studied twice. Once after dopamine depletion (with AMPT) and once after placebo. We will perform a 2-step hyperinsulinemic euglycemic clamp, using stable isotopes.
- Primary outcomeEndogenous glucose production.
- Secondary outcome1. Peripheral insulin sensitivity;
2. Lympathetic activity;
3. Glucoregulatory hormones.
- TimepointsWe will draw bloodsamples in the basal state, after de first and after the second step of the clamp.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES N.M. Lammers
- CONTACT for SCIENTIFIC QUERIES M.J.M. Serlie
- Sponsor/Initiator Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Endocrinology and Metabolism
- PublicationsN/A
- Brief summaryIt has been hypothesized that dopamine may be involved in the modulation of glucose metabolism. This hypothesis is partly based on the observation of the relationship between schizophrenia and diabetes and the finding that lean drug-naive schizophrenic patients display hepatic insulin resistance.
We will investigate glucose metabolism in healthy subjects after dopamine depletion with AMPT and placebo, using a hyperinsulinemic euglycemic clamp with stable isotopes.
- Main changes (audit trail)
- RECORD9-sep-2009 - 12-okt-2009


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