此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Oral Galactose as a Substrate for Post-Exercise Skeletal Muscle Glycogen Repletion in Individuals With Type 1 Diabetes

2026年8月17日 更新者:Ole Fuglsang-Jensen、University of Aarhus

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.

研究概览

地位

尚未招聘

详细说明

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.

研究类型

介入性

注册 (估计的)

16

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Ole Fuglsang-Jensen, master in sports science
  • 电话号码:+4527897650
  • 邮箱:AU664914@uni.au.dk

学习地点

      • Aarhus、丹麦、8000
        • steno diabetes center Aarhus
        • 接触:
          • Esben Søndergaard, Professor
          • 电话号码:+45
          • 邮箱:esbensoe@rm.dk
      • Aarhus、丹麦、8000
        • Aarhus Universitet
        • 接触:
          • Ole Fuglsang-Jensen

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
其他名称:
  • Galactose + glucose
有源比较器: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.
其他名称:
  • Galactose + glucose

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Skeletal muscle galactose uptake rate (μmol/min/g) measured by 2-(18)F-fluoro-2-deoxy-d-galactose (18F-FDGal)
大体时间:Measurement will be made on each of the two study days
Measurement will be made on each of the two study days

次要结果测量

结果测量
措施说明
大体时间
肝脏半乳糖摄取
大体时间:将在两个研究日的每一天进行测量
通过2-(18)F-氟-2-脱氧-d-半乳糖(18F-FDGal)测定的肝脏半乳糖摄取率(μmol/min/g)
将在两个研究日的每一天进行测量
Cerebral galactose Uptake
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年2月1日

初级完成 (估计的)

2028年9月1日

研究完成 (估计的)

2029年5月31日

研究注册日期

首次提交

2026年8月10日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅