Effect of Weight and Insulin Sensitivity on Reproductive Function in PCOS (PULSE)
2022年3月3日 更新者：Leanne Redman、Pennington Biomedical Research Center
Polycystic ovary syndrome (PCOS) is the most common reproductive disorder in women of reproductive age and despite decades of research the etiology the disorder is not known.
The characteristic hyperandrogenism and anovulation is associated with abnormal neuroendocrine function and insulin resistance.
Obesity is a common correlated phenotype of Polycystic ovary syndrome and weight gain worsens the reproductive and metabolic complications.
Currently there is no evidence-based treatment plan for infertility in Polycystic ovary syndrome; yet weight loss by dietary restriction and regular exercise are strongly advocated.
Weight loss and increased insulin sensitivity appear to drive improvements in reproductive outcomes in women with Polycystic ovary syndrome; however, the mechanism connecting these changes with the reproductive axis is not fully understood.
調査の概要
詳細な説明
The goal of this study is to determine (using dietary restriction, exercise training, metformin or no treatment), the effects of weight loss and/or improved insulin sensitivity on reproductive function (neuroendocrine and ovarian) in obese women with Polycystic ovary syndrome.
研究の種類
介入
入学 (実際)
32
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
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Louisiana
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Baton Rouge、Louisiana、アメリカ、70808
- Pennington Biomedical Research Center
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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
20年～40年 (大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria:
- 20 - 40 years, inclusive
- Body mass index ≥ 25 kg/m2
- History of irregular menstrual cycles (fewer than 6 cycles in the past year)
- Clinical and/or biochemical androgen excess (Free androgen index>3.85 and/or hirsuitism rating ≥8)
- Anovulatory menstrual cycles (determined during screening)
Exclusion Criteria:
- Ovulatory menstrual cycles (determined during screening by luteal phase serum progesterone >3ng/mL)
- History or clinical appearance of cardiovascular disease, diabetes (Type 1 or Type 2) and any other significant reproductive, metabolic, hematologic, pulmonary, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer.
- Hemoglobin, hematocrit, red blood cell count, or iron level below the lower limit of normal at the screening visit confirmed by a test repeated within two weeks
- Regular use of medications for weight control, glucose intolerance, thyroid disease
- Use of hormonal contraception containing medroxyprogesterone acetate (A 3 month washout period will be permitted for oral, vaginal and transdermal contraceptives).
Psychiatric and Behavioral Exclusion Criteria
- Smoking
- History of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years
- History or presence of an eating disorder as determined by Interview for Diagnosis of Eating Disorders (IDED-IV)
- Beck Depression Index (BDI) score of ≥15 at screening or baseline
Other Exclusion Criteria
- Individuals who have lost more than 5kg (11lbs) in the past 6 months
- Individuals who are pregnant or breast-feeding or whom become pregnant during the study
- Individuals engaged in a regular program of physical fitness involving some heavy physical activity (e.g., jogging or riding fast on a bicycle for 30 minutes or more) at least five times per week over the past year
- Individuals who have metallic objects in their body
- Individuals who donated blood within 30 days prior to the date of randomization
- Individuals unwilling to be assigned at random to either one of the intervention groups
- Unwilling or unable to adhere to the rigors of the data collection (determined by food and activities diaries at screening, see below) and clinical evaluation schedule over the entire 24 week intervention period
- Individuals who plan to move out of the area within the next 12 months or plan to be out of the study area for more than 4 weeks in the next 12 months
- Individuals who reside too far from Pennington
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：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
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Metformin
Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
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Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
他の名前：
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実験的：Dietary Restriction
Subjects randomized to the dietary restriction group (DR) will reduce their energy intake by 25% from their weight maintenance energy intake determined at baseline by doubly labeled water.There will be no gradual ramping of dietary restriction.
The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks.
Subjects will be asked to not modify their normal level of physical activity.
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Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline.
Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject.
There will be no gradual ramping of dietary restriction.
The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks.
Subjects will be asked to not modify their normal level of physical activity.
他の名前：
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実験的：Exercise
Subjects randomized to the exercise training group will complete a structured program of aerobic training 3 to 4 times per week and resistance exercises 2 times per week.
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For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW). The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch.
他の名前：
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介入なし：Control
Subjects randomized to the no treatment control group will be asked to continue, as normal their usual dietary and exercise regimen.
Subjects will be asked to not begin diet or exercise regimens through the 24-week study or to begin medical treatment for PCOS.
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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 |
|---|---|---|
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Luteinizing Hormone (LH) Pulse Frequency
時間枠：Baseline and Week 24
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Change in Luteinizing Hormone (LH) Pulse Frequency measured over a 12-hour period (7:00 PM - 7:00 AM). The Mean and Standard Deviation (SD) are the number of pulses recorded on the 12-hour period (7:00 PM - 7:00 AM) and presented as the change from baseline to week 24. Only participants who completed the PULSE trial are included in present outcome measure as the primary outcome was established as change from pre-to-post-intervention LF pulse frequency. |
Baseline and Week 24
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Insulin Sensitivity Expressed as Glucose Disposal Rate (GDR)
時間枠：Baseline and Week 24
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Change in insulin sensitivity measured by the euglycemic hyperinsulinemic clamp. Unit of measure established as glucose disposal rate (GDR) adjusted to account for kilograms of fat-free mass (FFM)+17.7 per minute to reflect the amount of exogenous glucose necessary to fully compensate for hyperinsulinemia and expressed as a function of metabolic body size. Only participants who completed the PULSE trial are included in present outcome measure as the primary outcome was established as change from pre-to-post-intervention Insulin Sensitivity expressed as Glucose Disposal Rate. |
Baseline and Week 24
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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：Leanne M Redman, PhD、Pennington Biomedical Research Center
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
- Broskey NT, Tam CS, Sutton EF, Altazan AD, Burton JH, Ravussin E, Redman LM. Metabolic inflexibility in women with PCOS is similar to women with type 2 diabetes. Nutr Metab (Lond). 2018 Oct 20;15:75. doi: 10.1186/s12986-018-0312-9. eCollection 2018.
- Broskey NT, Klempel MC, Gilmore LA, Sutton EF, Altazan AD, Burton JH, Ravussin E, Redman LM. Assessing Energy Requirements in Women With Polycystic Ovary Syndrome: A Comparison Against Doubly Labeled Water. J Clin Endocrinol Metab. 2017 Jun 1;102(6):1951-1959. doi: 10.1210/jc.2017-00459.
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)
2012年5月1日
一次修了 (実際)
2016年4月1日
研究の完了 (実際)
2016年12月1日
試験登録日
最初に提出
2011年11月28日
QC基準を満たした最初の提出物
2011年11月28日
最初の投稿 (見積もり)
2011年11月30日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月15日
QC基準を満たした最後の更新が送信されました
2022年3月3日
最終確認日
2022年3月1日
詳しくは
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。