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An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets 4상 120 식이 요법

미상
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임상시험 NCT04562454은(는) 기타을(를) 알아보기 위한 연구입니다. 이 연구는 당뇨병에 대해 진행되며, 4상 중재연구으로 현재 상태는 미상입니다. 연구는 2020년 10월 1일에 시작되어 120명의 참여자를 모집하고 있습니다. 베이징 셰허 의학원이(가) 진행하며, 2021년 10월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2020년 9월 24일에 갱신되었습니다.
간단한 개요
The glycemic index (GI) is used to evaluate the level of elevated blood sugar immediately after carbohydrate intake and is a classified indicator of the glycemic potential of carbohydrate-containing test foods relative to reference foods. At present, more and more clinical studies have proved that a low-GI diet is beneficial to health, and can improve blood glucose control, weight and blood lipid levels in patients w...더 보기
상세한 설명
In this study, subjects with diabetes or impaired glucose tolerance were given continuous glucose monitoring (CGM) for 3 consecutive days, given a standard meal containing 50g carbohydrates and foods to be tested for GI. The purpose of this study was to explore the fluctuation of blood glucose, the time and range of blood glucose peak after eating different diets, and to guide the individual dietary choices of the su...더 보기
공식 제목

An Exploratory Study on the Application of Continuous Glucose Monitoring System in the Measurement of Individual Glycemic Index After Eating Different Diets

질환명
당뇨병
기타 연구 식별자
  • 20200920-JS-2450
NCT 번호
NCT04562454
실제 연구 시작일
2020-10-01
최신 업데이트 게시
2020-09-24
예상 연구 완료일
2021-10-01
계획된 등록 인원
120
연구종류
중재연구
단계/상
4상
상태
미상
주요 목적
기타
설계 할당
비랜덤화 배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적Normal group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
실험적T1DM group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
실험적T2DM group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
실험적other type of diabetes group
Specific diet with CGM for 5days
Specific diet
use a specific diet in different days with CGM to konw GI of different food in diabetes
주요결과변수
결과변수측정값 설명시간 범위
fluctuation of blood glucose after eating different food
use the CGM to get the area under the curve of blood glucose of different food
baseline
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
건강한 참가자 허용
네
  1. the experimental group: patients with diabetes or impaired glucose tolerance diagnosed clinically according to the World Health Organization's (WHO) diagnostic criteria of diabetes in 1999; the control group: according to the participants of the experimental group, matched the people with normal glucose metabolism in sex, age and region.
  2. Age: 18-80 years old; 3) patients or family members who can understand the research plan and are willing to participate in this study and sign a written informed consent form and questionnaire

  1. severe acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmotic state, diabetic lactic acidosis) in the past 6 months;
  2. serious chronic complications of diabetes, such as peripheral vascular disease leading to amputation or chronic foot ulcers, end-stage renal disease, etc., the researchers do not think it is suitable to participate in this study.；
  3. patients with two or more episodes of severe hypoglycemia in the past year (such as disturbance of consciousness caused by hypoglycemia, coma, etc.), or severe unconscious hypoglycemia;
  4. patients with severe impairment or circulatory disturbance of cardiac function (NYHA grade III or above), liver function (ALT, AST or TBil above the upper limit of the normal value), renal function (serum creatinine above the upper limit of the normal value) or circulatory disturbance.；
  5. patients with mental illness, confusion and inability to take care of themselves;
  6. patients with gastrointestinal diseases;
  7. patients or their families cannot understand the conditions and objectives of this study
Peking Union Medical College Hospital logo베이징 셰허 의학원482개의 진행 중인 임상시험 탐색 가능
연구 대표 연락처
연락처: Weigang Zhao, MD, +86 69151876, [email protected]
연락처: Shuoning Song, 15117977900, [email protected]
시험기관의 위치 정보가 없습니다.