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Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT00299169
Recruitment Status : Terminated (insufficient recruitment/enrollment)
First Posted : March 6, 2006
Last Update Posted : January 8, 2008
Sponsor:
Information provided by:
Lawson Health Research Institute

Study Description
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Brief Summary:
Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels.

Condition or disease Intervention/treatment Phase
Diabetes Cardiovascular Disease Hyperlipidemia Behavioral: N of 1 Trials Phase 4

Detailed Description:

Cholesterol lowering medications called "statins" decrease heart disease in people with diabetes but research shows that many patients are not taking these medications, sometimes because of side effects. In our experience, the side effects attributed to statin therapy are often subjective, non-specific, and not associated with objective evidence for a clinically important problem. The most common example is muscle cramps despite a normal CK level, but other symptoms include fatigue, GI intolerance, and neurological symptoms.

Traditionally, the effects of treatments are determined using randomized controlled trials. N of 1 trials minimize these biases through randomization, double-blinding, and multiple crossovers, and are therefore excellent tools to evaluate adverse effects of therapies when symptoms are non-specific and objective evidence for a causal relationship is ambiguous.

Patients who are intolerant of statins in routine practice, but who lack objective evidence of significant harm, will be randomized to receive statins by either n of 1 trials or standard practice. Our hypothesis is that n of 1 trials will improve statin adherence, thereby improving low density lipoprotein cholesterol (LDL-C) levels. Patients in the n of 1 trials group will be given 1 month courses of either simvastatin or placebo. Patients in the group who are receiving statins according to standard practice will be given a prescription by the doctor in the usual way.

At the end of the study, we will determine if more patients participating in n of 1 trials group are taking statins compared to the patients in the conventional group and if this leads to lower cholesterol levels. We plan to use the results of this small feasibility study to test the methods and to plan a larger study on the same question.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
Study Start Date : September 2006
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
N of 1 trials of statin therapy
 Behavioral: N of 1 Trials
N of 1 Trials of statin therapy
Other Name: usual care
2
usual care
 Behavioral: N of 1 Trials
N of 1 Trials of statin therapy
Other Name: usual care


Outcome Measures
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Primary Outcome Measures :
  1. mean LDL levels [ Time Frame: end of study ]

Secondary Outcome Measures :
  1. the proportions of participants taking statins at the end of the trial [ Time Frame: end of study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Established diagnosis of type 1 or 2 diabetes
  • Age 18-80 years
  • Indication for a statin by the 2003 Canadian Diabetes Association (CDA) Clinical Practice Guidelines
  • Willingness to re-try a statin despite previous apparent intolerance
  • Provision of signed informed consent

Exclusion Criteria:

  • Contraindication to a statin: previous rhabdomyolysis, active liver disease or unexplained persistent elevations of serum transaminases (CK, AST, ALT >three times upper limit of normal), pregnancy or lactation
  • Impaired renal function: severe renal insufficiency (creatinine clearance <30 ml/min)
  • Presence of a condition such as malignancy for which the one-year prognosis is poor
  • Inability of the patient to comply with the rigorous conditions of the trial
  • Any other condition deemed to render the study harmful to the participant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299169


Locations
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Canada, Ontario
St. Joseph's Health Care London
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Charlotte G McDonald, MD Western University, Canada
More Information
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ClinicalTrials.gov Identifier: NCT00299169    
Other Study ID Numbers: R-06-135
IRF-061-05
First Posted: March 6, 2006    Key Record Dates
Last Update Posted: January 8, 2008
Last Verified: September 2006
Keywords provided by Lawson Health Research Institute:
N of 1 trial
diabetes mellitus
HMG CoA Reductase Inhibitors
cardiovascular disease
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Hyperlipidemias
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Dyslipidemias
Lipid Metabolism Disorders