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治験 NCT05387551（対象：耐糖能異常、前糖尿病）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
CGM and Lifestyle Changes in Patients With Impaired Glucose Tolerance 15 思春期 生活習慣
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT05387551 は 介入研究 臨床試験 で、耐糖能異常、前糖尿病 に関するものです。現在は 募集中 で、2022年12月1日 から開始しています。15 名の参加者 の募集が計画されています。この試験は Nemours Children's Clinic によって主導され、2026年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年11月26日 です。
概要
The incidence of type 2 diabetes (T2D) in children is increasing, paralleling the rising incidence of obesity. Preventing children and adolescents from developing T2D is critical. The health benefits of lifestyle modifications are well documented in this population, but success rates are low. Obesity in children and adolescents increases the risk of not only T2D but other complications as well, such as hypertension, ...もっと見る
詳細説明
The purpose of this research is to evaluate if having blood sugar information from a continuous glucose monitor (CGM) during activities of daily living provides additional benefit to lifestyle modifications in reducing the risk of developing diabetes and achieving a healthier weight. A CGM is a small device often worn on the back of the arm that uses a very small needle to insert a small sensor just under the skin in...もっと見る
公式タイトル
Effect of Adding Continuous Glucose Monitoring (CGM) to Lifestyle Changes on Insulin Sensitivity in Patients With Impaired Glucose Tolerance
疾患名
耐糖能異常前糖尿病その他の研究識別子
- lfox051622
NCT番号
開始日
2022-12-01
最終更新日
2025-11-26
終了予定日
2026-12
目標参加者数
15
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
impaired glucose tolerance
obesity
adolescents
obesity
adolescents
主目的
予防
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的CGM intervention Continuous glucose monitoring with real-time glucose data using Dexcom G6. | CGM Dexcom G7 sensor, transmitter and supplies will be provided to family for use. Participants will wear G7 and have real-time glucose data throughout the study. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Insulin Sensitivity Score (ISS) | Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance. | Baseline to 6 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
QUICKI insulin sensitivity | Change in insulin sensitivity as measured by QUICKI | Baseline to 3 months |
QUICKI insulin sensitivity | Change in insulin sensitivity as measured by QUICKI | Baseline to 6 months |
Insulin Sensitivity Score | Change in insulin sensitivity as measured by insulin sensitivity Score (ISS). The ISS directly correlates with insulin sensitivity. Higher scores indicate higher insulin sensitivity; lower scores indicate more insulin resistance. | Baseline to 3 months |
Glycemic levels | Change in characteristics of glycemic levels obtained from the CGM data. This will include:
* mean, standard deviation of glucose levels
* time in range (glucose between 70-140 mg/dL)
* percent of time with hyperglycemia (\>140 mg/dL)
* percent of time with hypoglycemia (\<70 mg/dL) | Baseline to 3 and 6 months |
Mean, standard deviation of sensor glucose levels | Change in characteristics of glycemic levels obtained from the CGM data, including mean and standard deviation of sensor glucose levels (mg/dL). | Baseline to 3 and 6 months |
Time in range of sensor glucose levels | Change in glycemic levels obtained from the CGM data: Percent of time in range (glucose between 70-140 mg/dL) | Baseline to 3 and 6 months |
Percent of sensor glucose levels in hypoglycemic range | Change in glycemic levels obtained from the CGM data: Percent of time with hypoglycemia (\<70 mg/dL) | Baseline to 3 and 6 months |
Percent of sensor glucose levels in hyperglycemic range | Change in glycemic levels obtained from the CGM data: Percent of time with hyperglycemia (\>140 mg/dL) | Baseline to 3 and 6 months |
Physical activity questionnaires | Questionnaires will be used to assess amount of time participants are active. Two questions regarding physical activity will be asked, with a scale set up as follows:
1. How many minutes of continuous physical activity per week were completed? Possible answers will be \<10, 11-20, 21-30, 31-60, 61-90, 91-120, or 121-150.
2. How many days per week of physical activity longer than 30 minutes? Possible answers will be 0, 1, 2, 3, 4, 5, 6, or 7. | 3 and 6 months |
Dietary compliance questionnaires | Questionnaires will be used to assess particpants' compliance witih dietary changes. Four questions regarding their diet will be asked, with a scale set up as follows:
1. How many sugary drinks per week? Possible answers will be 0, 1-2, 3-5, or \>5.
2. How many unhealthy snacks per week? Possible answers will be 0, 1-2, 3-5, or \>5.
3. How many times junk food was consume in the past week? Possible answers will be 0, 1-2, 3-5, or \>5.
4. How often were the proper portion sizes followed (as per control plate)? Possible answers will be always, most days, occasionally, or never. | 3 and 6 months |
参加アシスタント
適格基準
対象年齢
小児, 成人
試験の最低年齢
10 Years
対象性別
全て
- Children 10 to <18 years old (i.e., before their 18th birthday)
- Impaired glucose tolerance based on standardized oral glucose tolerance test (OGTT) or fasting glucose per American Diabetes Association criteria,
- Overweight or obese (BMI ≥85th percentile for age/sex)
- Patients are pubertal, defined as females with breast Tanner stage II or above, or males with testicular volume ≥4 mL
- Existing diagnosis of type 1 or type 2 diabetes
- Prepubertal
- Taking medications that affect insulin sensitivity (e.g.,chronic corticosteroids whether systemic or inhaled). Metformin allowed if stable dose.
- Patients and/or families not willing to wear the CGM for the duration of the study period or lack of compliance after recruitment
Nemours Children's Clinic責任者
Larry A. Fox, MD, 主任研究者, Division Chief, Nemours Children's Clinic
試験中央連絡先
連絡先: Larry Fox, MD, 9046973674, [email protected]
連絡先: Liezel Riego, 9046973431, [email protected]
1 1カ国の場所
Florida
Nemours Children's Clinic, Jacksonville, Florida, 32207, United States
Liezel Riego, 連絡先, 904-697-3431, [email protected]
Larry A Fox, MD, 主任研究者
募集中