Evaluation of Exercise, in Addition to Diet, in Women With Gestational Diabetes
2017年6月1日 更新者：Michel Boulvain、University Hospital, Geneva
The main objective is to evaluate the effect of therapeutic exercise program on blood glucose regulation in women with gestational diabetes mellitus (GDM) who are assigned to diet-and-exercise, compared to diet only (usual treatment).
The primary outcome is the need for insulin treatment in the two groups.
調査の概要
詳細な説明
In women with gestational diabetes, light to moderate daily physical activity may a useful therapeutic approach to improve the control of glycaemia and decrease the need for prescription of insulin. Increased physical activity in pregnant women with gestational diabetes is expected to decrease the mother and child morbidity associated with gestational diabetes, but also to improve the general health status of the mother and the child.
The objectives of this randomized trial are:
- To evaluate the effect of therapeutic exercise program on blood glucose regulation in women with GDM who are assigned to diet-and-exercise protocol.
- To demonstrate the feasibility of the therapeutic exercise treatment and the possibility of using the exercise program as an optional therapeutic approach for women with GDM.
研究の種類
介入
入学 (実際)
109
段階
- 適用できない
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
18年～50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:
- gestational diabetes, based on the criteria of Coustan-Carpenter, then on the International Association Diabetes Pregnancy Study Groups (IADPSG )
Exclusion Criteria:
- pre-existing diabetes
- twins
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：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：Exercise + diet
Exercise intervention: During the first session a standardized exercise prescription will be discussed with the participant. The exercise program will be of a moderate intensity, at less than 140 heart beats/min (which corresponds to 60% of the calculated maximum heart rate (HRmax) or 50% maximum oxygen volume (VO2max) ). A session of 30 to 60 minutes/week will be organised.
This is in addition to the diet (see below, control group) |
Once per week, participants will be enrolled in supervised group exercise intervention.
They will be encouraged in walking 45 minutes per day
|
|
介入なし：Diet only
Participants will receive diet counselling according to their characteristics.
The usual recommendation is to have a fractioned normocaloric diet (unless the dietician identify a grossly hypercaloric diet), with low fat and increase in fibers content.
|
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 |
|---|---|---|
|
Prescription of insulin during the follow-up
時間枠：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point.
|
The primary outcome will include any amount (dosage) of insulin and any frequency of injection.
Prescription of insulin is considered when glycaemia is above 5.3 mmol/L fasting and/or above 8.0 at 1 hour after the meal.
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery, usually 38 to 41 weeks of gestation). It is impossible in our context to give a specific time point.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Control of glycemia
時間枠：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
4 times per day, participants will check their blood sugar level.
The investigators will record these blood sugar levels and consider as normal if below 5.3 mmol/L fasting and below 8.0 at 1 hour after the meal.
Suboptimal glycemic control will be defined as 2 or more glycemia above these target values; good control will be defined as less than 2 values above the thresholds.
The variable "good glycemic control" will be coded "yes" if the above criteria (<2 abnormal values) are met, and "no" otherwise (>=2 abnormal values)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Compliance with the exercise (in the exercise group only)
時間枠：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Satisfactory compliance will be defined as walking at least 5000 steps/day 5 days a week and attending at 50% or more of the weekly supervised exercise program.
The variable "compliance" will be coded "yes" if both the above criteria are met, and "no" otherwise
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Timing of insulin treatment
時間枠：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
To better understand the effect of the intervention on the primary outcome, prescription of insulin), the investigators will compare between groups: Time between randomization and insulin prescription (days) |
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Gestational age at start of insulin treatment
時間枠：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
the investigators will compare between groups: Gestational age at start of insulin treatment (weeks) (mean ± SD)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Dosage of long-acting insulin
時間枠：From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Maximal dose of long-acting insulin per day (mean ± SD)
|
From inclusion in the study (randomization usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
|
Dosage of short-acting insulin
時間枠：usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
Maximal dose of short-acting insulin per day (mean ± SD)
|
usually between 24 and 30 weeks of gestation) until the end of pregnancy (delivery).
|
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：Michel Boulvain、Hôpitaux Universitaires de Genève
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)
2008年2月21日
一次修了 (実際)
2013年4月25日
研究の完了 (実際)
2013年6月19日
試験登録日
最初に提出
2017年1月24日
QC基準を満たした最初の提出物
2017年6月1日
最初の投稿 (実際)
2017年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2017年6月2日
QC基準を満たした最後の更新が送信されました
2017年6月1日
最終確認日
2017年6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。
Exerciseの臨床試験
-
National Taiwan Normal University完了
-
University of Erlangen-Nürnberg Medical SchoolKlinikum Nürnberg完了
-
University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical... と他の協力者完了
-
Chonticha KaewjohoUniversity of Phayao完了
-
Shanghai Jiao Tong University School of Medicine完了