Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
2022年4月8日 更新者：Yale University
To investigate whether the daily glucose profiles as assessed by continuous glucose monitoring for 1 week of normal weight and obese individuals relate to hunger levels and food intake.
調査の概要
詳細な説明
To evaluate the effect of blood glucose levels on eating behavior in a population of patients with diabetes in a free-living environment; the investigators plan to study lean healthy control subjects (BMI <25 kg/m2) and obese non-diabetic subjects (BMI > 30 kg/m2).
The participants who qualify will be invited to use the CGMS (DEXCOM G4 Platinum) for up to 7 days. On the visit for placement of the CGMS: 1) the participants will be explained by one of the study physicians how to use a glucometer (FreeStyle or Accu-Check), 2) they will have the CGMS inserted under the skin, and 3) they will be instructed how to fill up the food log (informational brochures are available at the end of the protocol. On the second visit (up to 7 days after the initial visit) the CGMS will be removed from the skin and the glucose meter and food log will be returned to the investigators.
When this study was initially designed, it incorporated 2 additional arms in the study: T1DM and obese T2DM patients. These patients were never recruited for the study.
研究の種類
介入
入学 (実際)
31
段階
- 適用できない
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
-
-
Connecticut
-
New Haven、Connecticut、アメリカ、06520
- Yale University School Of Medicine
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New Haven、Connecticut、アメリカ、06519-1362
- Yale New Haven Hospital
-
-
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～65年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- A1c < 10.5 %
Exclusion Criteria:
- BMI <18 (no upper limit),
- Creatinine > 1.5 mg/dL,
- Hgb < 10 mg/dL,
- ALT > 2.5 X ULN,
- untreated thyroid disease,
- uncontrolled hypertension,
- known neurological disorders,
- untreated psychiatric disorders,
- use of antidepressants and psychiatric medications,
- use of weight loss medications in the 6 months prior to the study,
- malignancy,
- smoking,
- current or recent steroid use in last 3 months,
- history of current illicit drug use;
- for women: pregnancy, or breastfeeding.
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：診断
- 割り当て：非ランダム化
- 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 |
|---|---|
|
アクティブコンパレータ：Lean Healthy Control
(BMI <25 kg/m2)
|
The CGMS consists of 3 parts: sensor, transmitter and monitor.
The small sensor measures the glucose levels from the interstitial tissue.
The transmitter is attached on top of the sensor and connects wirelessly to the monitor.
The sensor is sterile and comes in an unopened package.
It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels.
One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit.
The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch.
The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.
他の名前：
The Food Record will ask about amount and type of food consumed throughout the day.
The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity
|
|
アクティブコンパレータ：Obese non-diabetic subject
BMI > 30 kg/m2
|
The CGMS consists of 3 parts: sensor, transmitter and monitor.
The small sensor measures the glucose levels from the interstitial tissue.
The transmitter is attached on top of the sensor and connects wirelessly to the monitor.
The sensor is sterile and comes in an unopened package.
It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels.
One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit.
The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch.
The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.
他の名前：
The Food Record will ask about amount and type of food consumed throughout the day.
The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity
|
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 |
|---|---|---|
|
Rate of Changing Glucose Level
時間枠：3-5 days
|
The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the rate of changing glucose level (mg/dl/min).
|
3-5 days
|
|
Glucose Peak
時間枠：3-5 days
|
The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the glucose peak (mg/dl).
|
3-5 days
|
|
Glucose Nadir
時間枠：3-5 days
|
The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the glucose nadir (mg/dl).
|
3-5 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Glucose Peak and Nadir
時間枠：3-5 days
|
The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the difference in glucose peak and nadir (mg/dl).
|
3-5 days
|
|
Average Daily Hunger Rating
時間枠：3-5 days
|
Average daily hunger was measured using a self-report scale.
Hunger is measured on a scale from 1-10. 10 is the most hungry, 1 is the least hungry.
|
3-5 days
|
|
Nutirion Intake: Energy
時間枠：3-5 days
|
Data were collected through food journals.
Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R).
Presented is the average daily energy intake (kcal/day).
|
3-5 days
|
|
Nutirion Intake: Carbohydrate
時間枠：3-5 days
|
Data were collected through food journals.
Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R).
Presented is the average daily carbohydrate intake (g/day).
|
3-5 days
|
|
Nutirion Intake: Fat
時間枠：3-5 days
|
Data were collected through food journals.
Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R).
Presented is the average daily fat intake (g/day).
|
3-5 days
|
|
Nutirion Intake: Protein
時間枠：3-5 days
|
Data were collected through food journals.
Energy and macronutrient composition were calculated from self-reported food records based on Nutrition Data System for Research (NDS-R).
Presented is the average daily protein intake (g/day).
|
3-5 days
|
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。
スポンサー
捜査官
- 主任研究者：Renata Belfort De Aguiar, MD, PhD、Yale School of Medicine
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)
2016年2月1日
一次修了 (実際)
2017年12月14日
研究の完了 (実際)
2017年12月14日
試験登録日
最初に提出
2016年2月1日
QC基準を満たした最初の提出物
2016年2月2日
最初の投稿 (見積もり)
2016年2月3日
学習記録の更新
投稿された最後の更新 (実際)
2022年5月5日
QC基準を満たした最後の更新が送信されました
2022年4月8日
最終確認日
2022年4月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 1503015469
- 1K23DK098286-01A1 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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