Implications for Treatment of the Metabolic Syndrome
|ClinicalTrials.gov Identifier: NCT00666029|
Recruitment Status : Completed
First Posted : April 24, 2008
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome||Drug: atorvastatin Drug: placebo||Phase 2|
To characterise features of the metabolic syndrome, including body fat, insulin sensitivity, and liver fat together with muscle micorvascular blood flow.
To undertake a randomised controlled trial of atorvastatin 40 mg. o.d for 6 months to determine whether any of the above measures change with treatment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Implications for Treatment of the Metabolic Syndrome|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
U.S. FDA Resources
Active Comparator: Atorvastatin
Active arm atorvastatin 40 mg. o.d.
40 m.g. o.d. tablets for 6 months
Placebo Comparator: Placebo
Placebo arm dummy pill
- Muscle Microvascular Function [ Time Frame: 6 months ]Skeletal muscle microvascular function assessed (Filtrass plethysmographic system) using a passive inductive transducer (Compumedics.dwl, Singen, Germany) and a small pressure step venous congestion protocol. Fluid filtration rate (Jv mL min-1 100 mL-1), measured from the slope of limb volume change in response to each pressure step (10 mmHg steps to 60 mmHg around the thigh) over the last 2 minutes of its application, to allow for completion of vascular filling, and plotted against cuff pressure (Pcuff). The slope of this relationship, at pressures above those giving rise to net filtration, is a measure of Kf, microvascular filtration capacity, a function of exchange surface area and permeability. The CV for Kf measurement was 14.5%.
- Insulin Sensitivity Index [ Time Frame: 6 months ]Insulin sensitivity index was assessed during the final steady state 30 minutes of a high dose hyperinsulinaemic euglycaemic clamp (insulin infusion rate 1.5 mIU/kg/min). During this part of the clamp, insulin was infused at 1.5mIU/kg/min and the glucose concentration was maintained at 5 mmol/L using a dextrose infusion. The whole body insulin mediated glucose disposal rate (M value - mg/kg/min) was estimated from the total amount of glucose infused during the last 30 minutes of the clamp. The mean of four serum insulin concentrations was taken during this 30 minutes to determine the steady state insulin concentration (I value - milliunits/litre). M value/I value defined the insulin sensitivity index.