Oral Galactose as a Substrate for Post-Exercise Skeletal Muscle Glycogen Repletion in Individuals With Type 1 Diabetes
This Ph.D. project investigates whether orally ingested galactose can be taken up by skeletal muscle and the heart in response to exercise or hyperinsulinemia, and whether it may serve as a viable nutritional strategy for individuals with type 1 diabetes (T1D).
Although exercise provides significant health benefits for people with T1D, it is often associated with substantial glucose fluctuations and an increased risk of hypoglycemia. Conventional carbohydrate strategies based on glucose may further exacerbate glycemic instability due to the rapid increase in blood glucose levels. In contrast, galactose is metabolized more slowly and may therefore provide a more stable energy source during and after exercise.
Previous research has demonstrated that intravenously administered galactose is taken up by human skeletal muscle, with uptake increasing during exercise, suggesting a mechanism that may be at least partly insulin-independent. Building on these findings, this project aims to determine whether similar uptake occurs when galactose is ingested orally.
This study uses a randomized controlled design and applies non-invasive 18F-FDGal PET imaging to quantify galactose uptake in skeletal muscle and cardiac tissue. The findings may contribute to improving dietary recommendations for individuals with T1D, particularly in relation to maintaining stable blood glucose levels during and after physical activity.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
Previous studies using intravenously administered galactose have demonstrated direct uptake by human skeletal muscle, with uptake increasing following exercise. These findings challenge the traditional view that galactose must first be converted to glucose in the liver before utilization by peripheral tissues and suggest that exercise may stimulate galactose uptake through partly insulin-independent mechanisms. However, it remains unknown whether the tissue distribution and uptake kinetics of orally ingested galactose resemble those observed during intravenous administration.
The primary hypothesis is that prior exercise increases skeletal muscle galactose uptake. A secondary hypothesis is that co-ingestion of glucose reduces peripheral galactose uptake, potentially through increased hepatic extraction.
To investigate this, eight healthy participants and eight individuals with T1D will complete two study days in a randomized crossover design. On each study day, participants will perform 30 minutes of unilateral high-intensity leg exercise, with the non-exercised leg serving as an intra-individual control.
Following exercise, participants will ingest either 30 g galactose or 30 g galactose combined with 30 g glucose together with 100 MBq of ¹⁸F-FDGal. A 90-minute dynamic whole-body PET scan will be performed to characterize the tissue distribution and kinetics of ¹⁸F-FDGal, followed by a static brain scan. Tissue-specific time-activity curves will be extracted and, together with serial blood sampling, used for kinetic modeling of galactose uptake in skeletal muscle, liver, heart, and brain. Blood samples will be collected throughout the experiment to characterize systemic metabolic responses.
The unilateral exercise model enables direct within-participant comparison of galactose uptake between exercised and resting skeletal muscle, while the crossover design allows assessment of how glucose co-ingestion affects galactose distribution and uptake.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Ole Fuglsang-Jensen, master in sports science
- 電話番号：+4527897650
- メール：AU664914@uni.au.dk
研究場所
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-
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Aarhus、デンマーク、8000
- steno diabetes center Aarhus
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コンタクト：
- Esben Søndergaard, Professor
- 電話番号：+45
- メール：esbensoe@rm.dk
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Aarhus、デンマーク、8000
- Aarhus Universitet
-
コンタクト：
- Ole Fuglsang-Jensen
-
-
参加基準
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
説明
Inclusion Criteria:
- Healthy or T1D
- BMI 18,5-30 kg/m2
- Singed informed consent
Exclusion Criteria:
- Clinically significant heart, lung, kidney, liver, endocrine, or malignant disease based on information collected during the initial screening visit as well as blood tests
- Lack of awareness of hypoglycemia episodes
- Blood donation within the last 3 months
- Smoking
- Alcohol or substance abuse
- Participation in other studies involving ionizing radiation within the last 6 months
- Claustrophobia
- Inability to train one leg for one hour
研究計画
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：防止
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
アーム数
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 |
|---|---|
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実験的：Galactose
The patient will orally ingest 30 g of galactose.
|
Participants undergo two experimental conditions in a randomized crossover design.
In one condition, participants ingest 30 g of galactose, whereas in the other condition, they ingest 30 g of galactose combined with 30 g of glucose.
The order of the conditions is randomized across participants.
他の名前：
|
|
アクティブコンパレータ：Galactose + Glucose
The patient will orally ingest 30 g of galactose and 30 g of glucose.
|
Participants undergo two experimental conditions in a randomized crossover design.
In one condition, participants ingest 30 g of galactose, whereas in the other condition, they ingest 30 g of galactose combined with 30 g of glucose.
The order of the conditions is randomized across participants.
他の名前：
|
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 |
時間枠 |
|---|---|
|
Skeletal muscle galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)
時間枠：Measurement will be made on each of the two study days
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Measurement will be made on each of the two study days
|
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 |
|---|---|---|
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肝臓のガラクトース取り込み
時間枠：測定は 2 つの研究日のそれぞれに行われます。
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2-(18)F-フルオロ-2-デオキシ-d-ガラクトース（18F-FDGal）によって測定された肝臓のガラクトース取り込み速度（μmol/min/g）
|
測定は 2 つの研究日のそれぞれに行われます。
|
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Cerebral galactose Uptake
時間枠：Measurement will be made on each of the two study days
|
Galactose uptake in the brain, measured by a 10-minute static PET-CT scan performed after the 90-minute dynamic scan.
|
Measurement will be made on each of the two study days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
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
最初の投稿 (実際)
最初の投稿
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
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
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- 1-10-72-25-26 (その他の識別子：Research Ethics Committee Denmark)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
米国FDA規制機器製品の研究
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