NCT05806723

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
Last Updated

April 10, 2023

Status Verified

April 1, 2023

Enrollment Period

1.4 years

First QC Date

March 28, 2023

Last Update Submit

April 7, 2023

Conditions

Diabetes Mellitus, Type 2Dyslipidemia Associated With Type II Diabetes MellitusStatin Adverse ReactionHypogonadism, MaleAdrenal InsufficiencyVitamin D Deficiency

Keywords

type 2 diabetesstatintestosteronecortisolvitamin DDHEAS

Outcome Measures

Primary Outcomes (1)

  • change in testosterone level after atorvastatin treatment

    decrease in testosterone level

    six months

Secondary Outcomes (2)

  • change in cortisol level after atorvastatin treatment

    six months

  • change in DHEAS levels after atorvastatin treatment

    six months

Other Outcomes (1)

  • change in vitamin D level after atorvastatin treatment

    six months

Study Arms (1)

type 2 diabetic patients at high cardio vascular risk

EXPERIMENTAL

atorvastatin 40 mg a day for six months

Drug: Atorvastatin 40 Mg Oral Tablet

Interventions

Atorvastatin 40 Mg Oral TabletDRUG

daily drug intake during six months

type 2 diabetic patients at high cardio vascular risk

Eligibility Criteria

Age40 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale gender
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • male subjects
  • aged between 40 and 65 years
  • Type 2 diabetes
  • naive to statin
  • patients in whom a high intensity statin therapy was indicated according to the recommendations of the American Diabetes Association 2021 i.e in secondary cardio-vascular prevention or in primary prevention if the patient was aged more than 50 years or if other atherosclerotic cardiovascular disease risk factors were associated.

You may not qualify if:

  • the use within the last six months of drugs interfering with steroidogenesis (androgens, anti-androgens, Gn-RH analogues, corticosteroids, antiepileptics, barbiturates or other enzyme inducer or inhibitor)
  • history of endocrinopathy (hypogonadism, testicular tumor, pituitary insufficiency, adrenal insufficiency, uncontrolled hypothyroidism)
  • history of severe systemic disease (hepatic insufficiency, cirrhosis, alcoholism, severe or moderate renal insufficiency, symptomatic heart failure, chronic inflammatory disease)
  • myocardial infarction or stroke within the last six months
  • statin intolerance
  • withdrawal of consent
  • loss to follow-up
  • poor compliance with treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital La Rabta

Tunis, Tunisia

Location

Related Publications (1)

  • Chihaoui M, Terzi A, Hammami B, Oueslati I, Khessairi N, Chaker F, Yazidi M, Feki M. Effects of high-intensity statin therapy on steroid hormones and vitamin D in type 2 diabetic men: A prospective self-controlled study. Lipids. 2024 Sep;59(5):135-144. doi: 10.1002/lipd.12399. Epub 2024 May 20.

    PMID: 38764377DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2EunuchismAdrenal InsufficiencyVitamin D Deficiency

Interventions

AtorvastatinTablets

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHypogonadismGonadal DisordersAdrenal Gland DiseasesAvitaminosisDeficiency DiseasesMalnutritionNutrition Disorders

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDosage FormsPharmaceutical Preparations

Study Officials

  • Melika Chihaoui, Professor

    La rabta hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

March 1, 2021

Primary Completion

July 30, 2022

Study Completion

September 15, 2022

Last Updated

April 10, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
after the publication
Access Criteria
on request

Locations

TU(1)