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Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men

NCT05806723 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2023-04-10

No results posted yet for this study

Summary

The aim of the study was to assess the effect of high intensity statin therapy on testicular and adrenal steroids and vitamin D levels in type 2 diabetes males.It is a prospective study, conducted between march 2021 and July 2022, including 60 men with type 2 diabetes, aged 40 - 65 years, statin-free, and in whom a treatment with high intensity statin was indicated. The patients had two visits, before and six months after a daily intake of 40 mg of atorvastatin. During each visit, they underwent a clinical examination including the Androgen Deficiency in the Aging Male (ADAM) questionnaire and a fasting blood sample was collected for biological and hormonal measurements.

Conditions

  • Diabetes Mellitus, Type 2
  • Dyslipidemia Associated With Type II Diabetes Mellitus
  • Statin Adverse Reaction
  • Hypogonadism, Male
  • Adrenal Insufficiency
  • Vitamin D Deficiency

Interventions

DRUG

Atorvastatin 40 Mg Oral Tablet

daily drug intake during six months

Sponsors & Collaborators

  • Hopital La Rabta

    lead OTHER

Principal Investigators

  • Melika Chihaoui, Professor · La rabta hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-07-30
Completion
2022-09-15

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05806723 on ClinicalTrials.gov