DHEA and Testosterone Replacement in Elderly
Pathogenesis of Sarcopenia and Metabolic Changes in Aging
Sarcopenia is a major health problem among the rapidly expanding elderly population in our society. Disabilities directly related to muscle weakness, and indirectly related to changes in body composition and metabolic dysfunctions, are causing a staggering toll in disability and health care costs.
Osteopenia occurs almost simultaneously with sarcopenia in the elderly population and muscle weakness increases the risk for falls and therefore, fractures. Although these issues have been separate addressed in several studies, an integrated investigational approach to better understand the pathogenesis of sarcopenia and other age-related metabolic abnormalities and to investigate the potential role of androgens have not been undertaken in a comprehensive manner.
The program contains four independent research programs, each representing different research disciplines, and four separate cores supporting the four projects.
The main focus of the project is to determine the effect of the replacement of testosterone in elderly men and DHEA in elderly men and women and to compare these effects with placebo treatment over a two-year period.
Project 1, "Effect of Androgen Replacement on Muscle Metabolism" will specifically determine whether these interventions have a differential effect on size and quality of muscle in terms of strength and metabolic functions. Project 2, "Effect of Androgen Replacement on Bone Metabolism," will determine the effects of this intervention on bone mineral density and markers of bone turnover.
Project 3, "The Effect of Androgen Replacement on Carbohydrate Metabolism," will determine whether the age-associated decrease in circulating androgens contributes to the alterations in carbohydrate metabolism that are commonly observed in the elderly and on insulin action, insulin secretion, and glucose effectiveness.
Project 4, "Effect of Androgen Replacement on Fat Metabolism" will determine whether changes in fat distribution that occur with aging could result from differences in regional fatty acid uptake and systemic fatty acid kinetics, and whether these determinants of fat distribution are altered by the interventions.
The data emerging from these studies will be integrated to determine the intervention of sarcopenia with other metabolic changes and hopefully will contribute to a better understanding of muscle, bone, carbohydrate and fat metabolism.
This study will hopefully form the scientific basis for future trials of androgen replacement in the elderly.
調査の概要
研究の種類
入学
段階
- 適用できない
連絡先と場所
研究場所
-
-
Minnesota
-
Rochester、Minnesota、アメリカ、55905
- Mayo Clinic
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
bioavailable testosterone less than 103 nanogram/dl and DHEA-S level less than 157 microgram/dl for men; DHEA-S less than 95 microgram/dl for women;
Exclusion criteria:
significant ischemic heart disease, renal disease, uncontrolled hypertension, diabetes mellitus, malignancy, malabsorption, bone disorders, chronic obstructive pulmonary disease, or sleep apnea.
Others exclusion criteria include abnormal serum calcium, phosphorus, alkaline phosphatase, asparate aminotransferase, creatinine, urinary calcium, thyroid stimulating hormone, and erythrocyte sedimentation rate.
People taking medication that may affect outcome measures such as adrenal steroids, anticonvulsant therapy thiazide diuretics, and estrogen replacement were also excluded. People engaged in a regular exercise program lasting more than 20 minutes more than two times per week and those men whose PSA level (age adjusted upper limit) were also excluded.
研究計画
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:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:ダブル
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 |
---|
身体能力 (VO2 ピーク、チェスト プレス、ダブル ニー エクステンション、アイソキネティック ニー エクステンションで測定した筋力)
|
body composition (fat percent, fat free mass, abdominal visceral fat, and thigh muscle area)
|
bone parameters (BMD of ultradistal radius, femur neck, femur total and anterior-posterior of L2-L4 spine
|
fasting plasma insulin and glucose
|
二次結果の測定
結果測定 |
---|
生活の質
|
glucose and insulin after mixed meal
|
筋タンパク質合成
|
hormone levels
|
prostate size
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Nair KS, Rizza RA, O'Brien P, Dhatariya K, Short KR, Nehra A, Vittone JL, Klee GG, Basu A, Basu R, Cobelli C, Toffolo G, Dalla Man C, Tindall DJ, Melton LJ 3rd, Smith GE, Khosla S, Jensen MD. DHEA in elderly women and DHEA or testosterone in elderly men. N Engl J Med. 2006 Oct 19;355(16):1647-59. doi: 10.1056/NEJMoa054629.
- Espinosa De Ycaza AE, Rizza RA, Nair KS, Jensen MD. Effect of Dehydroepiandrosterone and Testosterone Supplementation on Systemic Lipolysis. J Clin Endocrinol Metab. 2016 Apr;101(4):1719-28. doi: 10.1210/jc.2015-4062. Epub 2016 Feb 17.
- Bush NC, Basu R, Rizza RA, Nair KS, Khosla S, Jensen MD. Insulin-mediated FFA suppression is associated with triglyceridemia and insulin sensitivity independent of adiposity. J Clin Endocrinol Metab. 2012 Nov;97(11):4130-8. doi: 10.1210/jc.2012-2285. Epub 2012 Aug 29.
- Srinivasan M, Irving BA, Frye RL, O'Brien P, Hartman SJ, McConnell JP, Nair KS. Effects on lipoprotein particles of long-term dehydroepiandrosterone in elderly men and women and testosterone in elderly men. J Clin Endocrinol Metab. 2010 Apr;95(4):1617-25. doi: 10.1210/jc.2009-2000. Epub 2010 Feb 5.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 547-96
- P01AG014383 (米国 NIH グラント/契約)
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Androgen Replacementの臨床試験
-
Caisson Interventional LLC積極的、募集していない僧帽弁閉鎖不全症 | 心臓弁膜症 | 弁膜症 | 僧帽弁疾患 | 僧帽弁不全 | 僧帽弁疾患アメリカ
-
University of OxfordUniversity of Copenhagen; Zimmer Biometわからない