Impact of Prasterone on Cardiometabolic Indicators in Perimenopausal Women.
2026年5月20日 更新者: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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
25
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Guanajuato
-
Mexico City、Guanajuato、メキシコ、36000
- Universidad de Guanajuato
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- with no history of breast cancer, HRT, morbid obesity, cardiovascular disease, or DM.
Exclusion Criteria:
-
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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)
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiometabolic risk
時間枠:Two months
|
The primary objective is to assess the impact of oral DHEA therapy in perimenopausal women on cardiometabolic indicators.
|
Two months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiometabolic risk
時間枠:0, 4 and 8 weeks
|
Assessing the effects of oral dehydroepiandrosterone (DHEA) therapy using the following indices:
|
0, 4 and 8 weeks
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Lorena Ibarra Reynoso, PhD、Universidad de Guanajuato
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2020年1月10日
一次修了 (実際)
2020年12月20日
研究の完了 (実際)
2021年1月10日
試験登録日
最初に提出
2023年4月1日
QC基準を満たした最初の提出物
2026年5月20日
最初の投稿 (実際)
2026年5月27日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月27日
QC基準を満たした最後の更新が送信されました
2026年5月20日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CIBIUG-P38-2016
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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Cardio Metabolic Riskの臨床試験
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Institute of Hematology & Blood Diseases Hospital...Hebei Taihe Chunyu Biotechnology Co., Ltd募集形質細胞白血病 | Ultra High Risk MM(UHR-MM)、18〜70歳、ASCTに適しています。次のUHR-MM定義のいずれかを満たします | 細胞遺伝学の超高リスク | 一次難治 | 早期進行 | 非麻痺性髄外浸潤 | R2-ISS-IV /MPSS-IV中国
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Duke UniversityNational Institute of Mental Health (NIMH); University of Pittsburgh; Harvard University完了
Prasterone 50 milligramの臨床試験
-
Wockhardt引きこもった