제1형 당뇨병 환자의 탄수화물 섭취 변화가 혈당 조절에 미치는 영향
2026년 9월 7일 업데이트: Yang Tao
제1형 당뇨병 환자의 탄수화물 섭취 변화가 혈당 조절에 미치는 영향.
혈당은 T1DM 환자, 특히 질병의 중기 및 후기 단계에서 크게 변동하며, 탄수화물(CHO)은 식후 포도당 반응(PGR)의 주요 결정 요인입니다.
영양 습관이 혈당 조절에 어떻게 영향을 미치는지 이해하기 위한 이전 조사를 바탕으로, 우리는 T1DM 환자를 대상으로 식이 중재 연구를 수행하여 식이 패턴 조정이 혈당 조절에 유익한지 여부를 탐색하고 관련 메커니즘의 탐지를 통해 관련 메커니즘을 추가로 탐색할 것입니다. 대사 지표.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
1. 주요 목적: 제1형 당뇨병 환자의 탄수화물 섭취 변화가 혈당 조절에 미치는 영향을 평가합니다.
- 1차 평가변수: 두 그룹 간의 범위 내 시간(TIR) 차이.
- 보조 끝점:
1) 두 그룹 사이의 변동계수(CV), 평균 혈당 변동폭(MAGE), 큰 혈당 변동 폭(LAGE)의 차이; 2) 두 그룹 간의 기준선 대비 HbA1c, GA, 1,5-안히드로글루시톨(1,5-AG) 변화의 차이; 3) 두 그룹 사이의 기준선 대비 저혈당 사건(%), 중증 저혈당증 및 야간 저혈당 사건 발생률의 변화 차이; 4) 두 그룹 간의 기준선 대비 인슐린 용량 변화(IU/kg/일)의 차이.
2. 2차 목표: 제1형 당뇨병 환자의 혈당 조절을 개선하기 위한 식이 중재의 가능한 메커니즘을 탐색합니다.
- 제1형 당뇨병 환자의 장내 미세환경 및 미생물총에 대한 식이 중재의 효과;
- 제1형 당뇨병 환자의 면역 기능에 대한 식이 중재의 효과;
- 제1형 당뇨병 환자의 대사체학에 대한 식이 중재의 효과.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
80
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Tao Yang, MD/PhD
- 전화번호: 6466 86-25-83718836
- 이메일: yangt@njmu.edu.cn
연구 장소
-
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Jiangsu
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Nanjing, Jiangsu, 중국, 210029
- 모병
- First Affiliated Hospital, Nanjing Medical University
-
연락하다:
- Tao Yang, PhD
- 전화번호: 6466 86-25-83718836
- 이메일: yangt@njmu.edu.cn
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 연구 참여에 동의하고 사전 동의서에 서명한 자
- 제1형 당뇨병의 진단(ADA2024);
- 18~65세
- 외인성 인슐린 요법(CSII)에 따라 치료 계획은 2개월 이내에 변경되지 않습니다(인슐린 유형은 변경할 수 없으며 용량은 혈장 포도당에 따라 조정 가능).
- 체질량지수(BMI) 18~24kg/m2;
- HbA1c ≤9.5%;
- 무작위 C-펩타이드 ≥200pmol/L.
제외 기준:
- 제1형 당뇨병을 앓고 있는 신혼여행객;
- 임신 중이거나 임신할 계획이 있는 여성;
- 채식주의자인 환자;
- 경구용 혈당강하제(알파글루코시다제 억제제, DPP-IV 억제제 등)를 복용하고 있는 환자
- 30일 이내에 글루코코르티코이드를 사용하고 있는 환자
- 심각한 음식 알레르기 병력;
- DKA와 같은 급성 합병증이 있는 환자;
- 위마비, 염증성 장질환 및 기타 합병증이 있는 환자;
- 알부민뇨가 많고 신부전증이 있는 환자;
- 조절되지 않는 갑상선 기능 항진증 및 갑상선 기능 저하증 환자;
- 심장 질환, 관상동맥 심장 질환 및 부정맥의 병력;
- 심각한 간 기능 장애(ALT 또는 AST > 정상 상한치의 1.5배)
- 악성 종양의 병력, 조절되지 않는 기타 면역체계 질환, 조절되지 않는 감염;
- 알코올 남용, 정신 장애 또는 약물 검사 관찰자로 적합하지 않은 기타 상태
- 연구 참여 또는 평가를 방해할 가능성이 있는 질병이 있는 환자.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: diverse carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 45-50% are derived from refined grains and 45-50% from whole grains and legumes.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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다른: moderate carbohydrate diet
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively. Of the staple carbohydrate sources, 90-95% are derived from refined grains. Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%. |
Carbohydrate, protein, and fat provide 45-55%, 15-20%, and 25-35% of total dietary energy, respectively.
Of the staple carbohydrate sources, 90-95% are derived from refined grains.
Total daily energy intake is divided among three meals, with breakfast providing 25-30% of total energy, lunch 30-40%, and dinner 30-35%.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time in range (TIR)
기간: 4 weeks (2 weeks after randomization)
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TIR is defined as the percentage of time that glucose levels are between 3.9 and 10.0 mmol/L, as measured by continuous glucose monitoring (CGM).
TIR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time above range(TAR)
기간: 4 weeks (2 weeks after randomization)
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TAR is defined as the percentage of time that glucose levels are above 10.0 mmol/L, as measured using continuous glucose monitoring (CGM).
TAR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Time below range(TBR)
기간: 4 weeks (2 weeks after randomization)
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TBR is defined as the percentage of time that glucose levels are below 3.9 mmol/L, as measured using continuous glucose monitoring (CGM).
TBR at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mean glucose (MG)
기간: 4 weeks (2 weeks after randomization)
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Mean glucose is defined as the arithmetic mean of all valid glucose values recorded during the 2-week continuous glucose monitoring (CGM) period.
Mean glucose at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Standard deviation of glucose (SD)
기간: 4 weeks (2 weeks after randomization)
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SD is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
SD at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glucose coefficient of variation (CV)
기간: 4 weeks (2 weeks after randomization)
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CV is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
CV at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Mean amplitude of glycemic excursions (MAGE)
기간: 4 weeks (2 weeks after randomization)
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MAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
MAGE at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Largest amplitude of glycemic excursions (LAGE)
기간: 4 weeks (2 weeks after randomization)
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LAGE is a continuous glucose monitoring (CGM)-derived measure of glycemic variability.
LAGE at the end of the 2-week dietary intervention will be compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glycated albumin (GA)
기간: 4 weeks (2 weeks after randomization)
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Glycated albumin will be measured at the end of the 2-week dietary intervention and compared between the two groups.
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4 weeks (2 weeks after randomization)
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Glycated hemoglobin A1c (HbA1c)
기간: 16 weeks (14 weeks after randomization)
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HbA1c will be measured at the end of the follow-up period and compared between the two groups.
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16 weeks (14 weeks after randomization)
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C-peptide area under the curve (AUC C-peptide)
기간: 16 weeks (14 weeks after randomization)
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C-peptide area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
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16 weeks (14 weeks after randomization)
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Glucagon area under the curve (AUC glucagon)
기간: 16 weeks (14 weeks after randomization)
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Glucagon area under the curve will be assessed during a 3-hour mixed-meal tolerance test and calculated using the trapezoidal rule.
The assessment will be performed in participants with fasting C-peptide >80 pmol/L.
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16 weeks (14 weeks after randomization)
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Fasting blood glucose (FBG)
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Fasting blood glucose will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total cholesterol (TC)
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total cholesterol will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Triglycerides (TG)
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Triglycerides will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Low-density lipoprotein cholesterol (LDL-C)
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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LDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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High-density lipoprotein cholesterol (HDL-C)
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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HDL-C will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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1,5-Anhydroglucitol (1,5-AG)
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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1,5-AG will be measured at the end of the dietary intervention and at the end of the follow-up period and compared between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total daily insulin dose
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Total daily insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Basal insulin dose
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Basal insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Prandial insulin dose
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Prandial insulin dose, expressed as IU/kg/day, will be assessed at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Body weight
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Body weight will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist circumference
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Hip circumference
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Hip circumference will be measured at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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Waist-to-hip ratio (WHR)
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Waist-to-hip ratio will be calculated from waist and hip circumference measurements at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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Body composition
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Body composition will be assessed using a body composition analyzer at the end of the dietary intervention and at the end of the follow-up period.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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Hypoglycemic events
기간: From randomization to the end of follow-up at 16 weeks
|
Hypoglycemic events will be assessed by the number of events per participant, the proportion of participants experiencing at least one hypoglycemic event, and the incidence rate of hypoglycemic events.
|
From randomization to the end of follow-up at 16 weeks
|
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Diabetic ketoacidosis (DKA)
기간: From randomization to the end of follow-up at 16 weeks
|
The number and proportion of participants experiencing diabetic ketoacidosis will be assessed and compared between the two groups.
|
From randomization to the end of follow-up at 16 weeks
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Gut microbiota profile
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Gut microbiota profiles will be assessed from fecal samples at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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Metabolomic profile
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
Metabolomic profiles will be assessed at the end of the dietary intervention and at the end of the follow-up period to evaluate differences between the two groups.
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4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
T-cell subset proportions
기간: 4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
The proportions of T-cell subsets will be assessed by flow cytometry at the end of the dietary intervention and at the end of the follow-up period.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Tao Yang, MD/PhD, First Affiliated Hospital, Nanjing Medical University, China
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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- Seidelmann SB, Claggett B, Cheng S, Henglin M, Shah A, Steffen LM, Folsom AR, Rimm EB, Willett WC, Solomon SD. Dietary carbohydrate intake and mortality: a prospective cohort study and meta-analysis. Lancet Public Health. 2018 Sep;3(9):e419-e428. doi: 10.1016/S2468-2667(18)30135-X. Epub 2018 Aug 17.
- Smart CE, Evans M, O'Connell SM, McElduff P, Lopez PE, Jones TW, Davis EA, King BR. Both dietary protein and fat increase postprandial glucose excursions in children with type 1 diabetes, and the effect is additive. Diabetes Care. 2013 Dec;36(12):3897-902. doi: 10.2337/dc13-1195. Epub 2013 Oct 29.
- Zhai X, Zhang L, Chen L, Lian X, Liu C, Shi B, Shi L, Tong N, Wang S, Weng J, Zhao J, Teng X, Yu X, Lai Y, Wang W, Li C, Mao J, Li Y, Fan C, Li L, Shan Z, Teng W. An Age-Specific Serum Thyrotropin Reference Range for the Diagnosis of Thyroid Diseases in Older Adults: A Cross-Sectional Survey in China. Thyroid. 2018 Dec;28(12):1571-1579. doi: 10.1089/thy.2017.0715. Epub 2018 Nov 27.
- Wong K, Raffray M, Roy-Fleming A, Blunden S, Brazeau AS. Ketogenic Diet as a Normal Way of Eating in Adults With Type 1 and Type 2 Diabetes: A Qualitative Study. Can J Diabetes. 2021 Mar;45(2):137-143.e1. doi: 10.1016/j.jcjd.2020.06.016. Epub 2020 Jun 27.
- Buehler LA, Noe D, Knapp S, Isaacs D, Pantalone KM. Ketogenic diets in the management of type 1 diabetes: Safe or safety concern? Cleve Clin J Med. 2021 Oct 1;88(10):547-555. doi: 10.3949/ccjm.88a.20121.
- Leow ZZX, Guelfi KJ, Davis EA, Jones TW, Fournier PA. The glycaemic benefits of a very-low-carbohydrate ketogenic diet in adults with Type 1 diabetes mellitus may be opposed by increased hypoglycaemia risk and dyslipidaemia. Diabet Med. 2018 May 8. doi: 10.1111/dme.13663. Online ahead of print.
- Vetrani C, Calabrese I, Cavagnuolo L, Pacella D, Napolano E, Di Rienzo S, Riccardi G, Rivellese AA, Annuzzi G, Bozzetto L. Dietary determinants of postprandial blood glucose control in adults with type 1 diabetes on a hybrid closed-loop system. Diabetologia. 2022 Jan;65(1):79-87. doi: 10.1007/s00125-021-05587-0. Epub 2021 Oct 23.
- Kanikarla-Marie P, Jain SK. Hyperketonemia and ketosis increase the risk of complications in type 1 diabetes. Free Radic Biol Med. 2016 Jun;95:268-77. doi: 10.1016/j.freeradbiomed.2016.03.020. Epub 2016 Mar 29.
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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)
연구 시작
2024년 8월 1일
기본 완료 (추정된)
기본 완료
2027년 12월 31일
연구 완료 (추정된)
연구 완료
2027년 12월 31일
연구 등록 날짜
최초 제출
최초 제출
2023년 2월 23일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2024년 2월 16일
처음 게시됨 (실제)
처음 게시됨
2024년 2월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 10일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 7일
마지막으로 확인됨
마지막으로 확인됨
2026년 9월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2022-SR-481.A3
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
미국에서 제조되어 미국에서 수출되는 제품
아니
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. .