- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07609043
Impact of Prasterone on Cardiometabolic Indicators in Perimenopausal Women.
20 maggio 2026 aggiornato da: Lorena del Rocio Ibarra Reynoso, Universidad de Guanajuato
Perimenopause is the natural transition period towards menopause, in which the ovarian reserve begins to decrease, and the woman loses her fertility.
It usually starts around the age of 40 and has a variable duration.
It has been identified that the decrease in estrogen levels leads to the development of metabolic and cardiovascular complications, such as metabolic syndrome.
Dehydroepiandrosterone (DHEA) is a hormone that converts to testosterone and estrogen and is mainly associated with age-related changes in cardiovascular tissues and metabolism, among others.
This hormone declines with age, contributing to the development of age-related disorders, such as cardiovascular disease.
In theory, DHEA has beneficial effects in regulating glucose and lipid metabolism and in ameliorating obesity.
It is hypothesized that DHEAS and cardiovascular disease may share causal pathways, for example, nitric oxide synthesis and endothelial cell damage.
In addition, it has been observed that the administration of DHEA significantly reduces the level of triglycerides and improves insulin sensitivity.
There are few studies focused on the perimenopause stage and none of them focused on the prevention of cardiometabolic risk.
Therefore, evaluating the impact of prasterone on cardiometabolic indicators in premenopausal women is essential.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Perimenopause is the natural transition period towards menopause, in which the ovarian reserve begins to decrease, and the woman loses her fertility.
It usually starts around the age of 40 and has a variable duration.
It has been identified that the decrease in estrogen levels leads to the development of metabolic and cardiovascular complications, such as metabolic syndrome.
Dehydroepiandrosterone (DHEA) is a hormone that converts to testosterone and estrogen and is primarily associated with age-related changes in cardiovascular tissues, female fertility, and metabolism, among others.
This hormone gradually declines with age, contributing to the development of age-related disorders, such as cardiovascular disease.
In theory, DHEA has beneficial effects in regulating glucose and lipid metabolism and in ameliorating obesity.
Previous studies have shown that DHEA is inversely associated with cholesterol levels, obesity, and diabetes, playing an important preventive role in cardiovascular disease.
It is hypothesized that DHEAS and cardiovascular disease may share causal pathways, for example, nitric oxide synthesis and endothelial cell damage.
Some studies in premenopausal women found inverse correlations between serum DHEA concentrations and body weight.
Besides.
It has been observed that the administration of DHEA significantly reduces the level of triglycerides and improves insulin sensitivity.
A meta-analysis showed that DHEAS was lower in patients with coronary disease, therefore, it is suggested that low levels of DHEAS may be a risk factor for coronary disease, affecting quality of life, and increasing the risks that predispose to metabolic diseases.
Most of the studies where DHEA is administered are focused on the menopause stage, there being few studies focused on the perimenopause stage and none of them on the prevention of Cardiometabolic risk.
For this reason, it is important to carry out studies to find out the effects that prasterone has on cardiometabolic indicators and that can contribute to the understanding of these processes before menopause appears.
This study was conducted in 25 women older than 42 years in the perimenopausal stage, with no history of breast cancer, hormonal replacement therapy , morbid obesity, cardiovascular disease, or diabetes mellitus.
They were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (baseline, one month and two months).
Anthropometric (weight, height, waist and hip circumference) and biochemical (glucose and cholesterol, triglycerides, HDL, LDL and VLDL) variables were evaluated, as well as blood pressure.
Cardiometabolic risk predictors were evaluated, such as the triglyceride-glycemia index, the triglyceride/HDL-C index, the waist-height index (WHtR), the cardiometabolic index, the Lipid Accumulation Product and visceral adiposity index.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
25
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
Guanajuato
-
Mexico City, Guanajuato, Messico, 36000
- Universidad de Guanajuato
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- with no history of breast cancer, HRT, morbid obesity, cardiovascular disease, or DM.
Exclusion Criteria:
-
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Prasterone prescription
The participantes were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (0, 4 and 8 weeks)
|
The participants were prescribed 50mg/day of prasterone for a period of 2 months, making 3 measurements (0, 4 and 8 weeks)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cardiometabolic risk
Lasso di tempo: Two months
|
The primary objective is to assess the impact of oral DHEA therapy in perimenopausal women on cardiometabolic indicators.
|
Two months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Cardiometabolic risk
Lasso di tempo: 0, 4 and 8 weeks
|
Assessing the effects of oral dehydroepiandrosterone (DHEA) therapy using the following indices:
|
0, 4 and 8 weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Lorena Ibarra Reynoso, PhD, Universidad de Guanajuato
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Anagnostis P, Bitzer J, Cano A, Ceausu I, Chedraui P, Durmusoglu F, Erkkola R, Goulis DG, Hirschberg AL, Kiesel L, Lopes P, Pines A, van Trotsenburg M, Lambrinoudaki I, Rees M. Menopause symptom management in women with dyslipidemias: An EMAS clinical guide. Maturitas. 2020 May;135:82-88. doi: 10.1016/j.maturitas.2020.03.007. Epub 2020 Mar 16.
- Rabijewski M, Papierska L, Binkowska M, Maksym R, Jankowska K, Skrzypulec-Plinta W, Zgliczynski W. Supplementation of dehydroepiandrosterone (DHEA) in pre- and postmenopausal women - position statement of expert panel of Polish Menopause and Andropause Society. Ginekol Pol. 2020;91(9):554-562. doi: 10.5603/GP.2020.0091.
- Teixeira CJ, Veras K, de Oliveira Carvalho CR. Dehydroepiandrosterone on metabolism and the cardiovascular system in the postmenopausal period. J Mol Med (Berl). 2020 Jan;98(1):39-57. doi: 10.1007/s00109-019-01842-5. Epub 2019 Nov 12.
- Vegunta S, Kling JM, Kapoor E. Androgen Therapy in Women. J Womens Health (Larchmt). 2020 Jan;29(1):57-64. doi: 10.1089/jwh.2018.7494. Epub 2019 Nov 5.
- Sahu P, Gidwani B, Dhongade HJ. Pharmacological activities of dehydroepiandrosterone: A review. Steroids. 2020 Jan;153:108507. doi: 10.1016/j.steroids.2019.108507. Epub 2019 Oct 3.
- Teixeira CJ, Ribeiro LM, Veras K, da Cunha Araujo LC, Curi R, de Oliveira Carvalho CR. Dehydroepiandrosterone supplementation is not beneficial in the late postmenopausal period in diet-induced obese rats. Life Sci. 2018 Jun 1;202:110-116. doi: 10.1016/j.lfs.2018.03.052. Epub 2018 Mar 27.
- Oh H, Wild RA, Manson JE, Bea JW, Shadyab AH, Pfeiffer RM, Saquib N, Underland L, Anderson GL, Xu X, Trabert B. Obesity, Height, and Serum Androgen Metabolism among Postmenopausal Women in the Women's Health Initiative Observational Study. Cancer Epidemiol Biomarkers Prev. 2021 Nov;30(11):2018-2029. doi: 10.1158/1055-9965.EPI-21-0604. Epub 2021 Aug 26.
- Tang J, Chen LR, Chen KH. The Utilization of Dehydroepiandrosterone as a Sexual Hormone Precursor in Premenopausal and Postmenopausal Women: An Overview. Pharmaceuticals (Basel). 2021 Dec 29;15(1):46. doi: 10.3390/ph15010046.
- Martinez-Garcia G, Rodriguez-Ramos M, Santos-Medina M, Mata-Cuevas LA, Carrero-Vazquez AM, Chipi-Rodriguez Y. Triglyceride-glucose index impact on in-hospital mortality in acute myocardial infarction. Results from the RECUIMA multicenter registry. Gac Med Mex. 2022;158(2):83-89. doi: 10.24875/GMM.M22000646.
- Lu Y, Liu S, Qiao Y, Li G, Wu Y, Ke C. Waist-to-height ratio, waist circumference, body mass index, waist divided by height0.5 and the risk of cardiometabolic multimorbidity: A national longitudinal cohort study. Nutr Metab Cardiovasc Dis. 2021 Aug 26;31(9):2644-2651. doi: 10.1016/j.numecd.2021.05.026. Epub 2021 Jun 4.
- Liu X, Wu Q, Yan G, Duan J, Chen Z, Yang P, Bragazzi NL, Lu Y, Yuan H. Cardiometabolic index: a new tool for screening the metabolically obese normal weight phenotype. J Endocrinol Invest. 2021 Jun;44(6):1253-1261. doi: 10.1007/s40618-020-01417-z. Epub 2020 Sep 9.
- Wu TT, Gao Y, Zheng YY, Ma YT, Xie X. Association of endogenous DHEA/DHEAS with coronary heart disease: A systematic review and meta-analysis. Clin Exp Pharmacol Physiol. 2019 Nov;46(11):984-994. doi: 10.1111/1440-1681.13146. Epub 2019 Aug 29.
- Wakabayashi I, Daimon T. The "cardiometabolic index" as a new marker determined by adiposity and blood lipids for discrimination of diabetes mellitus. Clin Chim Acta. 2015 Jan 1;438:274-8. doi: 10.1016/j.cca.2014.08.042. Epub 2014 Sep 6.
- Baez-Duarte BG, Zamora-Ginez I, Rodriguez-Ramirez SO, Pesqueda-Cendejas LK, Garcia-Aragon KH. TG/HDL index to identify subjects with metabolic syndrome in the Mexican population. Gac Med Mex. 2022;158(5):259-264. doi: 10.24875/GMM.M22000693.
- Farinola MG, Sganga M. [Cut-off points of anthropometric markers for hypertension and hyperglycemia in Argentine adults: a cross-sectional study from the 4th ENFR]. Rev Fac Cien Med Univ Nac Cordoba. 2022 Sep 16;79(3):260-266. doi: 10.31053/1853.0605.v79.n3.37313. Spanish.
- Qiao T, Luo T, Pei H, Yimingniyazi B, Aili D, Aimudula A, Zhao H, Zhang H, Dai J, Wang D. Association between abdominal obesity indices and risk of cardiovascular events in Chinese populations with type 2 diabetes: a prospective cohort study. Cardiovasc Diabetol. 2022 Nov 1;21(1):225. doi: 10.1186/s12933-022-01670-x.
- Vega-Cardenas M, Flores-Sanchez J, Torres-Rodriguez ML, Sanchez-Armass Capello O, Vargas-Morales JM, Cossio-Torres PE, Teran-Garcia M, Aradillas-Garcia C. [Distribution of triglycerides and glucose (TyG) index and homeostasis model assessment insulin resistance for the evaluation of insulin sensitivity on late adolescence in Mexicans]. Nutr Hosp. 2022 Dec 20;39(6):1349-1356. doi: 10.20960/nh.04120. Spanish.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
10 gennaio 2020
Completamento primario (Effettivo)
20 dicembre 2020
Completamento dello studio (Effettivo)
10 gennaio 2021
Date di iscrizione allo studio
Primo inviato
1 aprile 2023
Primo inviato che soddisfa i criteri di controllo qualità
20 maggio 2026
Primo Inserito (Effettivo)
27 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- CIBIUG-P38-2016
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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