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
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
Severe diabetes complications (e.g., advanced neuropathy)
Acute psychiatric disorder requiring treatment
Contraindications to massage (e.g., thrombosis, fever, infection, recent surgery)
Single group
Swedish massage
BehavioralParticipants receive Swedish massage once weekly for five consecutive weeks. Each 45-60-minute session is delivered by a licensed massage therapist using traditional Swedish techniques (kneading, gliding, and tapping) focusing on the back, shoulders, and neck. The intervention aims to promote relaxation and modulate stress-related biological systems. The study uses a single-group pre-post design to explore biological and psychological effects and feasibility.
Concentration of HbA1c (mmol/mol)
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 Copeptin (pmol/L)
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.
Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L)
Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower concentrations indicate reduced systemic inflammation
Concentration of Interleukin-6 (IL-6) (pg/mL)
Limited efficacy outcome assessing preliminary within-group inflammatory changes. Lower IL-6 levels indicate reduced inflammatory activation.
Change in Systolic Blood Pressure
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. Clinic systolic blood pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile.
Change in Diastolic Blood Pressure
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. Clinic systolic diastolic pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile.
Exploratory Metabolic and Inflammatory Markers
Additional biomarkers related to stress physiology, inflammation, or short-term glycemic control may be analyzed if relevant and assay-ready samples are available (e.g., additional cytokines, oxidative stress markers, or alternative glycemic indices). These outcomes are exploratory and not required for completion of the study.
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University Hospital, Linkoeping
Lead sponsor
Linkoeping University
Sponsor institution
Linkoeping University
Collaborator
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