A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes
調査の概要
詳細な説明
Insulin Resistance has been shown to put a person at risk for developing Type II diabetes. There is a correlation between sleep deprivation and insulin resistance.The study wants to assess the feasibility by enrolling 20 subjects in a year. The study also wants to assess the feasibility of the sleep extension intervention among young adults by examining the number of subjects that are randomized to intervention arm will complete the study.
Another intent of the study is to examine how sleep behaviors affect risks for developing type 2 diabetes and to determine their willingness to participate in a 4-week home-based program (intervention) focused on personal sleep behaviors.
Subjects enrolled in the study and are randomized to intervention group and control group. The intervention group will receive one education session consisting of strategies for sleep hygiene which is the routine for going to sleep and instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks. At the end of 4 weeks subjects will have a blood draw and will complete the questionnaires.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30303
- Georgia State University
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Atlanta、Georgia、アメリカ、30322
- Emory University
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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:
- Age must be 18-25 years old
- Self-report short sleep
- BMI ≥ 30 (the World Health Organization's classification of being obese)
- Insulin Resistance determined by serum analysis
- Be willing to extend time in bed by one hour total per night
- Read and speak English.
Exclusion Criteria:
- Night shift worker;
- Sleep disorder diagnosis;
- Medical diagnosis of diabetes or pre-diabetes;
- Currently pregnant or lactating or with history of gestational diabetes;
- Actively participating in a weight loss program;
- Hospitalization in past 3 months for any medical or psychiatric condition;
- Having a major chronic illness (e.g. cancer, Lupus)
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：防止
- 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 |
|---|---|
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実験的：Interventional Group
Intervention Group (SLEEP-Extend intervention): The SLEEP-Extend intervention consists of two components:
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他の：Control Group
Control group: consists of One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)
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Control group will receive 1.
One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)
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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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Number of Enrollments in the Study Over One Year
時間枠：Up to 12 months
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Feasibility of the study is assessed by number of enrollments in the study over a one year period.
Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.
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Up to 12 months
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Number of Participants Enrolled in the Intervention Arm Who Complete the Study
時間枠：Week 4
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Feasibility of the SLEEP-Extend intervention among young adults is measured by number of participants enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.
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Week 4
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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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Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores
時間枠：Baseline, Week 4
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The HOMA-IR score is used to measure severity of insulin resistance, though normal insulin resistance varies depending on the population.
HOMA-IR is calculated as blood glucose level (nmol/L) multiplied by insulin level (microU/L), divided by 22.5.
Elevated values indicate insulin resistance.
A cutoff score of HOMA-IR < 2.1 is considered normal and HOMA-IR ≥ 2.1 is considered to be evidence of insulin resistance.
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Baseline, Week 4
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Hours of Sleep
時間枠：Over a 1 week period at Baseline, and over a 1 week period at Week 4
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Using wrist actigraphy, this study will objectively monitor each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.
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Over a 1 week period at Baseline, and over a 1 week period at Week 4
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Number of Participants Extending Sleep
時間枠：Over a 1 week period at Baseline, and over a 1 week period at Week 4
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Sleep extension is assessed as the number of participants extending their nightly sleep by 1 to 2 hours from the baseline visit to the week 4 visit, as monitored using wrist actigraphy to measure each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.
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Over a 1 week period at Baseline, and over a 1 week period at Week 4
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Ashley Coombe, PhD, RN, CNE、Emory University
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
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。