Apolipoprotein B and low density lipoprotein size in type two diabetes: effect of atorvastatin and gemfibrozil

ISRCTN	ISRCTN58905233
DOI	https://doi.org/10.1186/ISRCTN58905233
Protocol serial number	ApoB-DM2
Sponsor	Hospital Sant Pau (Spain)
Funders	Catalonian Research Board (Spain) (ref: 1999 FI-712), Fund for Health Research (Fondo de Investigaciones Sanitarias [FIS]) (Spain) (ref: C03/08, PI052099 and PI051540), Pfizer (Spain) - study drugs and funding for some of the laboratory measurements were provided

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Ana M Wägner
Scientific

Endocrinology Department
Hospital Sant Pau
S Antonio M Claret 167
Barcelona
08025
Spain

Email	awagner@santpau.es

Primary study design	Interventional
Study design	Open-label randomised cross-over trial
Secondary study design	Randomised controlled trial
Scientific title	Apolipoprotein B and low density lipoprotein size in type two diabetes: effect of atorvastatin and gemfibrozil
Study objectives	Lipid-lowering drugs have complementary and additive effects on the components of diabetic dyslipidaemia and markers of inflammation in type two diabetes.
Ethics approval(s)	Approval received from local Ethics Committee (Fundacio de Gestio Sanitaria de L'Hospital de la Santa Creu i Sant Pau IRB) in late 1998.
Health condition(s) or problem(s) studied	Type two diabetes
Intervention	Patients will receive either: 1. Atorvastatin 10 - 20 mg/d 2. Gemfibrozil 900 - 1200 mg/d For 12 weeks, and then will receive: 3. 10 mg atorvastatin and 900 mg gemfibrozil combined for 12 additional weeks
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Atorvastatin and gemfibrozil
Primary outcome measure(s)	Effect on components of diabetic dyslipidaemia (especially apoB and LDL size).
Key secondary outcome measure(s)	Concentrations of inflammatory markers.
Completion date	01/05/2001

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	40
Total final enrolment	44
Key inclusion criteria	1. Men and women with type two diabetes, aged 35 to 75 years 2. No treatment known to interfere with lipid metabolism (nonselective B-blockers, high dose diuretics, systemic steroids, lipid-lowering drugs) in the month preceding inclusion in the study 3. Plasma Low Density Lipoprotein cholesterol (LDLc) greater than 100 mg/dl (2.6 mmol/litre), and triglycerides less than 400 mg/dl (4.51mmol/litre)
Key exclusion criteria	1. Pregnant 2. No reliable contraceptive method was used 3. Serum creatinine more than 1.7 mg/dl (150 umol/litre) 4. Hepatic dysfunction (transaminases greater than 1.5 times upper normal limit at inclusion) 5. Creatine kinase more than three times the upper normal limit 6. Acute or chronic disorders that might interfere with compliance
Date of first enrolment	01/05/1999
Date of final enrolment	01/05/2001

Endocrinology Department

Barcelona
08025
Spain

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/07/2003		Yes	No

14/11/2022: Total final enrolment added.