A Study for Pre-diabetic Patients With Cholesterol Lowering Drugs

Effects of Simvastatin and Rosiglitazone Combination in Patients With the Metabolic Syndrome.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00831129

Acronym

SIROCO

Enrollment

Registered

2009-01-28

Start date

2006-09-30

Completion date

2011-04-30

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes

Brief summary

The purpose of this research study is to examine if a combination of a cholesterol lowering-drug, simvastatin, with a sugar-lowering drug called rosiglitazone is more effective in improving vascular inflammation (irritation of the vessels that transport your blood) and other cardiovascular risk factors than the taking of simvastatin alone.

Detailed description

Age 21-75 years Metabolic syndrome (must have 3 of the 5 components) elevated waist circumference \>40inches in men, \>35 inches in women elevated triglycerides \>150mg/dL reduced HDL \<40mg/dL in men\<50 in women elevated blood pressure \>130mmHg systolic, or \>85mmHg diastolic elevated fasting glucose \>100mg/dL

Interventions

DRUGRosiglitazone

4 mg daily

DRUGPlacebo Rosiglitazone

1 tab daily

DRUGSimvastatin

40 mg daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* 21-75 years * Metabolic syndrome (3 of the 5 components) * Elevated waist circumference \>40inches in men, \>35inches in women * Elevated triglycerides \>150mg/dL * Reduced HDL \<40mg/dL in men, \<50mg/dL in women * Elevated blood pressure \>130mmHg systolic, \>85mmHg diastolic * Elevated fasting glucose \>100mg/dL

Exclusion criteria

* Diabetes mellitus * Stage 3 hypertension \>180mmHg systolic, \>110mmHg diastolic office blood pressure * History of non-diabetic kidney disease * Myocardial infarction of unstable angina within the past 6 months * History of liver disease * History of malignancy * History of drug or alcohol abuse * Treatment with corticosteroids * Pregnancy or lactating women of women of child bearing potential who are not willing to use reliable contraception method during the study

Design outcomes

Primary

Measure	Time frame	Description
Change in High-sensitivity C-reactive Protein	Baseline and 6 months	change in high-sensitivity C-reactive between baseline and 6 month

Secondary

Measure	Time frame	Description
Change in Urinary Isoprostane	Baseline and 6 months	change in urinary isoprostane between baseline and 6 month
Change in Malondialdehyde	Baseline and 6 months	change in Malondialdehyde between baseline and 6 month
Change in Office Systolic Blood Pressure	Baseline and 6 months	change in office systolic blood pressure between baseline and 6 month
Change in Office Diastolic Blood Pressure	Baseline and 6 months	change in office diastolic blood pressure between baseline and 6 month
Change in (Ambulatory Blood Pressure Monitoring) Systolic Blood Pressure	Baseline and 6 months	change in (ambulatory blood pressure monitoring) systolic blood pressure between baseline and 6 month
Change in (Ambulatory Blood Pressure Monitoring) Diastolic Blood Pressure	Baseline and 6 months	change in (ambulatory blood pressure monitoring) diastolic blood pressure between baseline and 6 month
Change in Low-density Lipoprotein	Baseline and 6 months	change in low-density lipoprotein between baseline and 6 month
Change in Homeostatic Model Assessment for Insulin Resistance	Baseline and 6 months	change in homeostatic model assessment for insulin resistance between baseline and 6 month
Change in High-density Lipoprotein	Baseline and 6 months	change in high-density lipoprotein between baseline and 6 month
Change in Glycosylated Haemoglobin	Baseline and 6 months	change in glycosylated haemoglobin between baseline and 6 month
Change in Fasting Blood Glucose	Baseline and 6 months	change in fasting blood glucose between baseline and 6 month
Change in Insulin	Baseline and 6 months	change in Insulin between baseline and 6 month
Change in Adiponectin	Baseline and 6 months	change in Adiponectin between baseline and 6 month
Change in Body Mass Index	Baseline and 6 months	change in body mass index between baseline and 6 month
Change in Triglycerides	Baseline and 6 months	change in Triglycerides between baseline and 6 month

Countries

United States

Participant flow

Participants by arm

Arm	Count
Placebo simvastatin 40 mg/day plus placebo	20
Rosiglitazone simvastatin 40 mg/day plus rosiglitazone 4 mg/day	23
Total	43

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	9 lost to follow-up reasons uknown	0	9
Overall Study	Adverse Event	0	1

Baseline characteristics

Characteristic	Placebo	Rosiglitazone	Total
Age, Continuous	55.1 years STANDARD_DEVIATION 9.3	58.7 years STANDARD_DEVIATION 12.1	57.03 years STANDARD_DEVIATION 10.7
Gender Female	6 Participants	14 Participants	20 Participants
Gender Male	14 Participants	9 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	6 / 20	9 / 23
serious Total, serious adverse events	0 / 20	0 / 23