Investigation Into the Effects of Blood Glucose Levels Upon Eating Behavior in Lean and Obese Non-diabetic and Diabetic Subjects
2022년 4월 8일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
31
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Connecticut
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New Haven, Connecticut, 미국, 06520
- Yale University School of Medicine
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New Haven, Connecticut, 미국, 06519-1362
- Yale New Haven Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Lean Healthy Control
(BMI <25 kg/m2)
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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.
다른 이름들:
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
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활성 비교기: 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.
다른 이름들:
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
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rate of Changing Glucose Level
기간: 3-5 days
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The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the rate of changing glucose level (mg/dl/min).
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3-5 days
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Glucose Peak
기간: 3-5 days
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The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the glucose peak (mg/dl).
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3-5 days
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Glucose Nadir
기간: 3-5 days
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The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the glucose nadir (mg/dl).
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3-5 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in Glucose Peak and Nadir
기간: 3-5 days
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The CGM sensor measures the glucose levels from the interstitial tissue.
Presented is the difference in glucose peak and nadir (mg/dl).
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3-5 days
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Average Daily Hunger Rating
기간: 3-5 days
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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.
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3-5 days
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Nutirion Intake: Energy
기간: 3-5 days
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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).
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3-5 days
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Nutirion Intake: Carbohydrate
기간: 3-5 days
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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).
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3-5 days
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Nutirion Intake: Fat
기간: 3-5 days
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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).
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3-5 days
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Nutirion Intake: Protein
기간: 3-5 days
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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).
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3-5 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Renata Belfort De Aguiar, MD, PhD, Yale School of Medicine
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 2월 1일
기본 완료 (실제)
2017년 12월 14일
연구 완료 (실제)
2017년 12월 14일
연구 등록 날짜
최초 제출
2016년 2월 1일
QC 기준을 충족하는 최초 제출
2016년 2월 2일
처음 게시됨 (추정)
2016년 2월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 5월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 4월 8일
마지막으로 확인됨
2022년 4월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 1503015469
- 1K23DK098286-01A1 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Continuous Glucose Monitoring System (CGMS)에 대한 임상 시험
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Singapore General HospitalKK Women's and Children's Hospital; SingHealth Polyclinics완전한