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van CCT (UK)

van CCT (UK)

60 hours of fasting and it's relationship with insulin resistance and mitochondrial function.

- candidate number6508
- NTR NumberNTR2042
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-sep-2009
- Secondary IDsMEC 06-3-095 METC University Maastricht
- Public Title60 hours of fasting and it's relationship with insulin resistance and mitochondrial function.
- Scientific TitleProlonged fasting-induced skeletal muscle lipid accumulation and insulin resistance: pathological response or physiological adaptation.
- ACRONYMStarvation study
- hypothesisProlonged fasting-induced lipid accumulation accompanied by increased levels of DAG and ceramide, will interfere with insulin signaling explaining the insulin resistant glucose uptake. High levels off FFA might cause a decreased oxidative capacity
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Insulin resistance, Mitochondrail function, Oxidative capacity
- Inclusion criteria1. Male sex;
2. Age 18-35 years;
3. BMI <25 kg/m2;
4. Sedentary;
5. Stable dietary habits;
6. Healthy;
7. No (first or second-degree) family member with diagnosed type 2 diabetes.
- Exclusion criteria1. Female sex;
2. Unstable body weight (weight gain or loss > 3 kg in the past three months);
3. Participation in a regular exercise training program during the last year before the start of the study;
4. Any medical condition requiring treatment and/or medication use;
5. Abuse of drugs and/or alcohol;
6. Participation in another biomedical study within 1 month before the first screening visit.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-jan-2007
- planned closingdate10-jan-2010
- Target number of participants12
- Interventions12 healthy subjects wiil undergo in random order a 60h fast (calorie-free drinks only (S)) or a control diet (50-35-15% of energy as CHO, fat and protein (FED)). During the study, subjects stayed in a respiration chamber to measure energy expenditure and substrate oxidation. Insulin-sensitivity was assessed using a hyperinsulinemic-euglycemic clamp. Muscle biopsies and blood samples were taken after each intervention period in basal and insulin-stimulated conditions. Oxidative capacity is measured with an oxygraph.
- Primary outcomePrimary outcome parameters are skeletal muscle lipid accumulation and insulin sensitivity.
- Secondary outcomeSecondary outcome measures are mitochondrial damage/oxidative capacity, Substrate oxidation en Energy expenditure
- TimepointsInsulin sensitivity is assesed after 60 hours, biopsies are taken after 60 hours in basal and insulin stimulated condition. Additional blood samples are taken after 12,36 and 60 hours.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator University Maastricht (UM), NUTRIM
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM), NUTRIM
- PublicationsN/A
- Brief summarySkeletal muscle mitochondrial dysfunction has been linked to the development of insulin resistance and type 2 diabetes mellitus. We have suggested that muscle mitochondrial dysfunction may result from lipotoxicity: fat accumulation in skeletal muscle – as observed in insulin resistance and diabetes - could lead to impaired mitochondrial function. Interestingly, prolonged fasting (short-term ‘starvation’) also results in intramyocellular lipid accumulation and insulin resistance. Whether the mechanisms underlying are comparable, is unknown and aim of the present study.
- Main changes (audit trail)
- RECORD22-sep-2009 - 5-mrt-2010

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