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Completed

NCT Number: NCT00130481

Pediatric Atorvastatin in Diabetes Intervention Trial (PADIT)

The purpose of this study is to determine if Atorvastatin can improve blood vessel stiffness and blood vessel function in children 10-18 years old with Type 1 and Type 2 diabetes. Subjects will receive atorvastatin 20mg or placebo daily for 3 months and will then switch therapies for the next 3 months.

Hypothesis: Atorvastatin will improve blood vessel function by decreasing arterial stiffness and improving blood flow.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) for more than 1 year
  • Age 10-18 years.

Exclusion criteria

  • Cardiovascular disease (CVD)
  • Liver disease
  • Pregnancy
  • Use of cholesterol or triglyceride lowering drugs
  • Perceived inability to comply with the study protocol
  • Endocrinopathy other than diabetes

Treatment and study plan

Atorvastatin 20 mg daily for 3 months

Drug

Primary outcomes

  1. Augmentation Index (arterial stiffness)

  2. ENDO-PAT (Peripheral Arterial Tone) score (endothelial function)

  3. Low density lipoprotein

Secondary outcomes

  1. Urine microalbumin

  2. Pubertal stage

  3. Body mass index (BMI)

  4. Blood pressure

  5. Glycated hemoglobin (HbA1c)

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2005
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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