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Trial Outcomes & Findings for Implications for Treatment of the Metabolic Syndrome (NCT NCT00666029)

NCT ID: NCT00666029

Last Updated: 2019-01-23

Results Overview

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%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

6 months

Results posted on

2019-01-23

Participant Flow

Participant milestones

Participant milestones
Measure
Atorvastatin
Active arm atorvastatin 40 mg. o.d. Participants randomised to atorvastatin: 40 m.g. o.d. tablets for 6 months
Placebo
Placebo arm dummy pill placebo: Placebo
Overall Study
STARTED
20
20
Overall Study
COMPLETED
19
20
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Implications for Treatment of the Metabolic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Atorvastatin
n=20 Participants
Active arm atorvastatin 40 mg. o.d. atorvastatin: 40 m.g. o.d. tablets for 6 months Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with \> 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides \>2.0 mmol/L - a cardinal lipid abnormality of the syndrome.
Placebo
n=19 Participants
Placebo arm dummy pill placebo: Placebo Age 18-75 years, body mass index (BMI) 20-35 kg/m2, with \> 3 criteria for the metabolic syndrome , one of which will be hypertriglyceridaemia, i.e. fasting plasma triglycerides \>2.0 mmol/L - a cardinal lipid abnormality of the syndrome.
Total
n=39 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=5 Participants
19 Participants
n=7 Participants
39 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Continuous
51.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
51.4 years
STANDARD_DEVIATION 9.0 • n=7 Participants
51.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male
Female
12 Participants
n=5 Participants
10 Participants
n=7 Participants
22 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants
9 Participants
n=7 Participants
17 Participants
n=5 Participants
Region of Enrollment
United Kingdom
20 participants
n=5 Participants
19 participants
n=7 Participants
39 participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: There was missing data on two participants in the atorvastatin arm and two participants in the placebo arm.

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%.

Outcome measures

Outcome measures
Measure
Atorvastatin
n=17 Participants
Active arm atorvastatin 40 mg. o.d. atorvastatin: 40 m.g. o.d. tablets for 6 months
Placebo
n=18 Participants
Placebo arm dummy pill placebo: Placebo
Muscle Microvascular Function
3.7 10^3 mL*min^-1*100ml^-1*mmHg^-1
Standard Deviation 1.4
4.0 10^3 mL*min^-1*100ml^-1*mmHg^-1
Standard Deviation 1.1

PRIMARY outcome

Timeframe: 6 months

Population: There was missing data in four people in the atorvastatin arm and two people in the placebo arm

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.

Outcome measures

Outcome measures
Measure
Atorvastatin
n=15 Participants
Active arm atorvastatin 40 mg. o.d. atorvastatin: 40 m.g. o.d. tablets for 6 months
Placebo
n=18 Participants
Placebo arm dummy pill placebo: Placebo
Insulin Sensitivity Index
0.56 mg*kg^-1*min^-1*mIU^-1*L^-1
Standard Deviation 0.21
0.41 mg*kg^-1*min^-1*mIU^-1*L^-1
Standard Deviation 0.14

Adverse Events

Atorvastatin

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Atorvastatin
n=20 participants at risk
Active arm atorvastatin 40 mg. o.d. atorvastatin: 40 m.g. o.d. tablets for 6 months
Placebo
n=20 participants at risk
Placebo arm dummy pill placebo: Placebo
Musculoskeletal and connective tissue disorders
muscle ache
5.0%
1/20 • Adverse event data collected over 6 months
0.00%
0/20 • Adverse event data collected over 6 months

Other adverse events

Adverse event data not reported

Additional Information

Professor Christopher Byrne

University Hospital Southampton

Phone: +44 238120 5006

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place