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van CCT (UK)

van CCT (UK)

GM3 and insulin sensitivity.

- candidate number4541
- NTR NumberNTR1540
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-nov-2008
- Secondary IDsMEC 08/280 
- Public TitleGM3 and insulin sensitivity.
- Scientific TitleGM3 and insulin sensitivity.
- hypothesisWe hypothesize that membrane-residing gangliosides are elevated in obese insulin resistant subjects and correlate to peripheral insulin resistance.
Furthermore, we hypothesize that the perturbation of the insulin signaling cascade by elevated gangliosides is caused by a reduced phosphorylation of the insulin receptor.
- Healt Condition(s) or Problem(s) studiedObesity, Insulin sensitivy, Diabetes Mellitus, Insulin resistance
- Inclusion criteriaInclusion criteria for all participants
1. Written informed consent
2. Caucasian
3. Able to keep a normal day and night rhythm during the study period (i.e. no shift work)
4. Stable weight for at least 3 months
5. Age 20-55 years

Inclusion criteria for healthy volunteers: 1. 20 BMI 25 kg/m2
2. Fasting glucose level of < 5.6 mmol/L, in addition to a glucose level of < 7.8 mmol/L at 2 hours after intake of 75 g glucose (OGTT).

Inclusion criteria for obese subjects: 1. BMI >30 kg/m2
2. Fasting glucose level of < 7 mmol/L, in addition to a glucose level of < 11.0 mmol/L at 2 hours after intake of 75 g glucose (OGTT).
3. HOMA IR > 2.7
- Exclusion criteriaExclusion criteria for all participants:
1. Participation in an investigational drug trial within 90 days prior to our study
2. history of or current abuse of drugs or alcohol (>14 U/week)
3. Smoking 4. Vigorous physical activity
5. Family history of DM II
6. Familial dyslipidemia
7. Any medical condition except hypertension and dyslipidemia in the obese group
8. Use of any medication except for anti-hypertensives, excluding ACE-inhibitors/AII-antagonists.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 10-dec-2008
- planned closingdate10-dec-2010
- Target number of participants20
- InterventionsNone:
This is a comparitive study; 10 obese men mached for gender and age with 10 lean men.
- Primary outcome- Peripheral glucose uptake (Rd)
- Ganglisosides concentration in muscle and adipose tissue
- Secondary outcome- Plasma concentration of glucoregulatory hormones
- Energy expenditure
- Carbohydrate oxidation and fat oxidation
- VO2 max
- Muscle fiber type
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- 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 summaryGangliosides reside within the plasma membrane and are able to modulate insulin signaling at the level of the insulin receptor. The most abundant ganglioside is GM3. Recently, we and others have shown in rats that pharmacologically reducing GM2 and GM3 levels results in amelioration of high fat diet induced insulin resistance. In this study we want to explore if gangliosides are elevated in muscle and adipose tissue of obese subjects inslin resistant subjects compared to matched healthy controls.
- Main changes (audit trail)
- RECORD18-nov-2008 - 27-nov-2008

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