1 型糖尿病患者の血糖コントロールに対する炭水化物摂取量の変化の影響
2026年9月7日 更新者：Yang Tao
1 型糖尿病患者の血糖コントロールに対する炭水化物摂取量の変化の影響。
T1DM 患者の血糖は、特に病気の中期および後期で大きく変動し、炭水化物 (CHO) が食後血糖反応 (PGR) の主な決定要因です。
栄養習慣が血糖コントロールにどのような影響を与えるかを理解するための以前の研究に基づいて、T1DM患者を対象とした食事介入研究を実施して、食事パターンの調整が血糖コントロールに有益であるかどうかを調査し、関連する症状の検出を通じて関連メカニズムをさらに調査します。代謝指標。
調査の概要
状態
状態
募集
条件
条件
介入・治療
介入・治療
詳細な説明
1. 主な目的: 1 型糖尿病患者の血糖コントロールに対する炭水化物摂取量の変化の影響を評価すること。
- 主要エンドポイント: 2 つのグループ間の範囲内時間 (TIR) の差。
- 二次エンドポイント:
１）２つのグループ間の変動係数（ＣＶ）の差、血糖変動の平均振幅（ＭＡＧＥ）、血糖変動の大振幅（ＬＡＧＥ）； 2) 2 つのグループ間の HbA1c、GA、1,5-アンヒドログルシトール (1,5-AG) のベースラインからの変化の差。 ３）２群間のベースラインからの低血糖事象、重度の低血糖事象および夜間低血糖事象の発生率の変化（％）の差。 ４）２つのグループ間のベースラインからのインスリン用量の変化（ＩＵ／ｋｇ／日）の差。
2. 第 2 の目的: 1 型糖尿病患者の血糖コントロールを改善するための食事介入の可能なメカニズムを調査すること。
- 1 型糖尿病患者の腸内微小環境および微生物叢に対する食事介入の影響。
- 1 型糖尿病患者の免疫機能に対する食事介入の影響。
- 1 型糖尿病患者のメタボロミクスに対する食事介入の影響。
研究の種類
研究の種類
介入
入学 (推定)
入学
80
段階
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。
研究連絡先
研究連絡先
- 名前：Tao Yang, MD/PhD
- 電話番号：6466 86-25-83718836
- メール：yangt@njmu.edu.cn
研究場所
-
-
Jiangsu
-
Nanjing、Jiangsu、中国、210029
- 募集
- First Affiliated Hospital, Nanjing Medical University
-
コンタクト：
- Tao Yang, PhD
- 電話番号：6466 86-25-83718836
- メール：yangt@njmu.edu.cn
-
-
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
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- 研究に参加することに同意し、インフォームドコンセントに署名する人。
- 1 型糖尿病 (ADA2024) の診断。
- 年齢は18～65歳。
- 外因性インスリン療法 (CSII) に応じて、治療計画は 2 か月以内は変更されません (インスリンの種類は変更できず、血漿グルコースに応じて投与量は調整できます)。
- 体格指数 (BMI) が 18 ～ 24 kg/m2。
- HbA1c ≤9.5%;
- ランダム C ペプチド ≥200pmol/L。
除外基準:
- 1 型糖尿病の新婚旅行者。
- 妊娠中または妊娠を計画している女性。
- ベジタリアンの患者。
- 経口血糖降下薬（α-グルコシダーゼ阻害薬、DPP-IV阻害薬など）を使用している患者。
- 30日以内にグルココルチコイドを使用している患者。
- 重度の食物アレルギーの病歴;
- DKAなどの急性合併症のある患者。
- 胃不全麻痺、炎症性腸疾患、その他の合併症のある患者。
- 多量のアルブミン尿および腎不全の患者。
- 制御されていない甲状腺機能亢進症および甲状腺機能低下症の患者。
- 心臓病、冠状動脈性心臓病、不整脈の既往歴;
- 重篤な肝機能障害（ALTまたはASTが正常の上限の1.5倍を超える）。
- 悪性腫瘍、制御されていない他の免疫系疾患、制御されていない感染症の病歴;
- アルコール乱用、精神障害、または薬物検査の観察者として不適切なその他の症状。
- 何らかの疾患を患っている患者は、研究への参加や評価を妨げる可能性があります。
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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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他の：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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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time in range (TIR)
時間枠：4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time above range(TAR)
時間枠：4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
|
Time below range(TBR)
時間枠：4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
|
Mean glucose (MG)
時間枠：4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
|
Standard deviation of glucose (SD)
時間枠：4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
|
Glucose coefficient of variation (CV)
時間枠：4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
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Mean amplitude of glycemic excursions (MAGE)
時間枠：4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
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Largest amplitude of glycemic excursions (LAGE)
時間枠：4 weeks (2 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization)
|
|
Glycated albumin (GA)
時間枠：4 weeks (2 weeks after randomization)
|
Glycated albumin will be measured at the end of the 2-week dietary intervention and compared between the two groups.
|
4 weeks (2 weeks after randomization)
|
|
Glycated hemoglobin A1c (HbA1c)
時間枠：16 weeks (14 weeks after randomization)
|
HbA1c will be measured at the end of the follow-up period and compared between the two groups.
|
16 weeks (14 weeks after randomization)
|
|
C-peptide area under the curve (AUC C-peptide)
時間枠：16 weeks (14 weeks after randomization)
|
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.
|
16 weeks (14 weeks after randomization)
|
|
Glucagon area under the curve (AUC glucagon)
時間枠：16 weeks (14 weeks after randomization)
|
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.
|
16 weeks (14 weeks after randomization)
|
|
Fasting blood glucose (FBG)
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Total cholesterol (TC)
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Triglycerides (TG)
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Low-density lipoprotein cholesterol (LDL-C)
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
High-density lipoprotein cholesterol (HDL-C)
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
1,5-Anhydroglucitol (1,5-AG)
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Total daily insulin dose
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Basal insulin dose
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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Prandial insulin dose
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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Body weight
時間枠：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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
Waist circumference
時間枠：4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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
時間枠：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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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Waist-to-hip ratio (WHR)
時間枠：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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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Body composition
時間枠：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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
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Hypoglycemic events
時間枠：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)
時間枠：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
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その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gut microbiota profile
時間枠：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
時間枠：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.
|
4 weeks (2 weeks after randomization) and 16 weeks (14 weeks after randomization)
|
|
T-cell subset proportions
時間枠：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)
|
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。
捜査官
捜査官
- 主任研究者：Tao Yang, MD/PhD、First Affiliated Hospital, Nanjing Medical University, China
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
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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)
研究開始
2024年8月1日
一次修了 (推定)
一次修了
2027年12月31日
研究の完了 (推定)
研究の完了
2027年12月31日
試験登録日
最初に提出
最初に提出
2023年2月23日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2024年2月16日
最初の投稿 (実際)
最初の投稿
2024年2月22日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年9月10日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年9月7日
最終確認日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- 2022-SR-481.A3
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。