- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04805996
The eHealth Diabetes Remission Trial - Pilot Study (eDIT-pilot)
Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c < 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended.
The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Umeå, 스웨덴, 90187
- Department of Public Health and Clinical Medicine, Medicine
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Type 2 diabetes with diabetes duration 0 to 6 years
- BMI 27-45 kg/m2
- Owning a smartphone
- HbA1c 43-107 mmol/mol during the past 12 months (48-107 mmol/mol without blood sugar lowering medication)
Exclusion Criteria:
- Insulin treatment
- Weight loss 5 kg or more during the past 6 months
- Treatment with weight loss medication
- Diagnosed eating disorder
- eGFR < 30 ml/min/1.73m2
- Substance abuse
- Cancer
- Myocardial infarction during the past 6 months
- Severe heart failure
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
This study has only one arm and no comparator.
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행동: Diabetes remission using total diet replacement and eHealth contact with the healthcare provider
Participants will replace usual foods with the commercially available total diet replacement Modifast (Impolin AB), which is delivered to them during the study period without any cost.
Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor and will be advised to measure body weight, fasting blood glucose and blood pressure every morning.
The results are registered in the mobile phone application Telia Health Monitoring (Telia Sweden AB) and are wirelessly transmitted to the study team.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Weight loss
기간: 6 months
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Weight loss goal of 15 kg, measured at the research facilities
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6 months
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HbA1c
기간: 6 months
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The goal is diabetes remission with HbA1c < 48 mmol/mol without any diabetes medication.
(Secondary goal < 42 mmol/mol.)
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6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Semi-structured interviews
기간: 6 months
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6 months
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Fasting blood glucose
기간: Daily measurements up to 6 months
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Partial diabetes remission (< 7.0 mol/l), complete diabetes remission (<6.1 mol/l)
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Daily measurements up to 6 months
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Fasting blood glucose
기간: 6 months
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Partial diabetes remission (<7.0 mol/l), complete diabetes remission (<6.1 mol/l) without diabetes medication.
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6 months
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P-glucose 120 minutes after the oral glucose tolerance test
기간: 6 months
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Measured at the research facilities
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6 months
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Insulin secretion
기간: At baseline, 3 months and 6 months
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Measured with oral glucose tolerance test
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At baseline, 3 months and 6 months
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Insulin sensitivity
기간: At baseline, 3 months and 6 months
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Measured with oral glucose tolerance test
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At baseline, 3 months and 6 months
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Metabolic flexibility
기간: At baseline, 3 months and 6 months
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Measured with indirect calorimetry during oral glucose tolerance test
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At baseline, 3 months and 6 months
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Blood pressure (systolic/diastolic)
기간: At baseline, 3 months and 6 months
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Measured at the research facilities
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At baseline, 3 months and 6 months
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Blood pressure (systolic/diastolic)
기간: Daily measurements up to 6 months
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Measured at home
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Daily measurements up to 6 months
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Blood pressure medication
기간: 6 months
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Change of blood pressure medication during the study
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6 months
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Body weight
기간: Daily measurements up to 6 months
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Measured at home
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Daily measurements up to 6 months
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HbA1c
기간: Monthly measurement up to 6 months
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Measured at home
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Monthly measurement up to 6 months
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Diabetes medication
기간: 6 months
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Change of diabetes medication during study duration
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6 months
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Plasma lipid profile
기간: At baseline, 3 months and 6 months
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Measured at the research facilities
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At baseline, 3 months and 6 months
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Waist circumference
기간: Baseline, 3 months and 6 months
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Measured in cm at the research facilities
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Baseline, 3 months and 6 months
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EQ-5D-5L
기간: At baseline, 3 months and 6 months
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Questionnaire
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At baseline, 3 months and 6 months
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Food frequency form
기간: At baseline and 6 months
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Questionnaire
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At baseline and 6 months
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Daily steps
기간: During the second three months of the study
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Measured with activity tracker
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During the second three months of the study
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HbA1c follow up
기간: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Body weight follow up
기간: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Blood pressure follow up (systolic/diastolic)
기간: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Antidiabetic medication usage follow up
기간: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Blood pressure medication usage follow up
기간: Yearly up to 20 years
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Collected from patient journals after study completion
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Yearly up to 20 years
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Diabetes complications follow up
기간: Yearly up to 20 years
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Collected from patient journals and registries after study completion
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Yearly up to 20 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
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