Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05806723 |
| Other study ID # |
HLaRabta22021 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2021 |
| Est. completion date |
September 15, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Hopital La Rabta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study design and setting It is a prospective study carried out at the department of
Endocrinology of the University Hospital La Rabta, Tunis, between March 2021 and July 2022.
The protocol was approved by La Rabta University Hospital local ethics committee.
Subjects Inclusion criteria were male subjects, aged between 40 and 65 years, with T2D, naive
to statin and 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.
All patients gave an informed written consent to participate in the study. Exclusion criteria
were 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.
The number of subjects required for the study was calculated. When considering alpha= 0.05,
beta= 0.10, and a magnitude of difference in testosterone levels of 0.59 ng/ml according to
Dobs AS et al. study with an estimated common standard deviation of 1.0, the number of
subjects required is estimated to be 50.
Protocol and data collection Visit 1: inclusion visit. The subjects were included and signed
an informed consent to participate in the study. Visits 1 and 2 were performed on the same
day in fasting patients.
Visit 2:
Clinical data were determined: age; habits; history; ongoing treatment; signs of adrenal
insufficiency (weight loss, anorexia, asthenia, dizziness on standing, signs of
hypoglycemia); signs of hypogonadism (decreased libido, presence or absence of nocturnal
erections); number of sexual intercourses per month. Patients responded to the androgen
deficiency in the aging male questionnaire (ADAM) translated to Tunisian dialect by four
physicians from the same department.
Patients underwent a physical examination: measure of weight, height, and lying and standing
blood pressure, presence of melanoderma, gynecomastia or myalgia.
A blood sample was collected between 8 a.m. and 9 a.m., after 12 hours of fasting, for the
measurement of glucose, HbA1c, total cholesterol, triglycerides, high density lipoprotein
cholesterol (HDLc), creatinine, sodium, potassium, transaminases (alanine aminotransferase
(ALT) and aspartate aminotransferase (AST)), creatine phosphokinase (CPK), calcium,
phosphate, albumin, total testosterone, sex hormone binding globulin (SHBG), estradiol,
follicle stimulating hormone (FSH), luteinizing hormone (LH), cortisol, DHEAS
(dehydroepiandrosterone sulfate), parathormone (PTH), and 25-hydroxy vitamin D. Blood samples
were frozen at -20°c at the laboratory until hormonal measurements.
Treatment with 40 mg atorvastatin a day was initiated in all patients.
Visit 3: after six months of treatment:
The clinical and paraclinical parameters determined at visit 1 were determined again. The
dose and the compliance of statin intake were evaluated by Girerd questionnaire. The
occurrence of clinical adverse events of statin such as myalgia, arthralgia, digestive
symptoms was recorded.
