Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes (TOUCH-D): A Pilot Single-group Feasibility Study Evaluating Biological and Psychological Effects of Swedish Massage in Adults With Type 1 Diabetes.
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- University Hospital, Linkoeping
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Concentration of HbA1c (mmol/mol)
概览
简要总结
This pilot study evaluates potential biological and psychological effects of Swedish massage in adults with type 1 diabetes. Massage may influence stress-related mechanisms, such as hypothalamic-pituitary-adrenal (HPA) axis activity and inflammation, which are linked to impaired insulin sensitivity and glycemic control. Twenty participants with type 1 diabetes will receive weekly 45-60-minute Swedish massage sessions for five weeks. Biological outcomes include HbA1c, fasting glucose, copeptin, hs-CRP, IL-6, and TNF-α. Glycemic variability will be assessed using continuous glucose monitoring (CGM). Psychological outcomes include perceived stress (PSS-10) and anxiety (GAD-7). The study aims to explore feasibility, acceptability, and preliminary within-group effects on stress regulation and glycemic balance
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open-label single-group pilot study; neither participants nor investigators are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years) with type 1 diabetes ≥ 1 year
- •Able to attend two assessment visits at Vrinnevi Hospital
- •Uses CGM or equivalent system
- •Able to communicate in Swedish and provide consent
排除标准
- •Severe diabetes complications (e.g., advanced neuropathy)
- •Acute psychiatric disorder requiring treatment
- •Contraindications to massage (e.g., thrombosis, fever, infection, recent surgery)
结局指标
主要结局
Concentration of HbA1c (mmol/mol)
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
This measure is part of the study's limited efficacy evaluation and is used to explore preliminary within-group changes in preparation for a future randomized trial. HbA1c (mmol/mol), measured from fasting blood samples. Lower values indicate improved glycemic control.
Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L)
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower concentrations indicate reduced systemic inflammation
Concentration of Interleukin-6 (IL-6) (pg/mL)
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower IL-6 levels indicate reduced inflammatory activation.
Glycemic variability (Coefficient of Variation, %), measured by CGM
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Limited efficacy outcome assessing preliminary within-group changes in glycemic stability. Lower %CV indicates more stable glucose levels.
Concentration of Copeptin (pmol/L)
时间窗: Baseline and within 7 days after final massage (5 weeks).
Limited efficacy outcome assessing preliminary within-group changes related to physiological stress. Copeptin measured from fasting serum samples. Lower concentrations indicate reduced stress system activation.
Time in Range (percentage of CGM readings between 3.9-10 mmol/L)
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation.
Score on the Perceived Stress Scale-10 (PSS-10)
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Limited efficacy outcome assessing preliminary within-group psychological changes. The PSS-10 is a 10-item scale ranging 0-40, with higher scores indicating greater perceived stress.
Score on the Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Limited efficacy outcome assessing preliminary within-group psychological changes. The GAD-7 ranges 0-21, with higher scores indicating more severe anxiety.
Concentration of fasting plasma glucose (mmol/L)
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Limited efficacy outcome assessing preliminary within-group metabolic changes prior to a future randomized trial. Fasting plasma glucose (mmol/L), with lower values indicating improved glycemic control.
Mean interstitial glucose (mmol/L) measured by continuous glucose monitoring (CGM)
时间窗: Change from baseline to within 7 days after the fifth massage session (5 weeks).
Limited efficacy outcome assessing preliminary within-group changes in glycemic control. Mean interstitial glucose derived from CGM. Lower values indicate improved glycemic control.
次要结局
- Change in Systolic Blood Pressure(Baseline and within 7 days after the final massage session (5 weeks).)
- Change in Diastolic Blood Pressure(Baseline and within 7 days after the final massage session (5 weeks).)
研究者
Peter Johansson
Professor
Linkoeping University