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NCT Number: NCT07275086

Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes

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

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Johansson

Norrköping, Linköpings Universitet, 601 74, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Severe diabetes complications (e.g., advanced neuropathy)
  • Acute psychiatric disorder requiring treatment
  • Contraindications to massage (e.g., thrombosis, fever, infection, recent surgery)

Treatment and study plan

Swedish Massage

Behavioral

Participants 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.

Primary outcomes

  1. Concentration of HbA1c (mmol/mol)

    Time frame: 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.

  2. Concentration of Copeptin (pmol/L)

    Time frame: 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.

  3. Concentration of high-sensitivity C-reactive protein, hs-CRP (mg/L)

    Time frame: 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

  4. Concentration of Interleukin-6 (IL-6) (pg/mL)

    Time frame: 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.

  5. Mean interstitial glucose (mmol/L) measured by continuous glucose monitoring (CGM)

    Time frame: 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.

  6. Glycemic variability (Coefficient of Variation, %), measured by CGM

    Time frame: 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.

  7. Time in Range (percentage of CGM readings between 3.9-10 mmol/L)

    Time frame: 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.

  8. Score on the Perceived Stress Scale-10 (PSS-10)

    Time frame: 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.

  9. Score on the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 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.

  10. Concentration of fasting plasma glucose (mmol/L)

    Time frame: 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.

Secondary outcomes

  1. Change in Systolic Blood Pressure

    Time frame: Baseline and within 7 days after the final 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.

    Clinic systolic blood pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile.

  2. Change in Diastolic Blood Pressure

    Time frame: Baseline and within 7 days after the final 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.

    Clinic systolic diastolic pressure (mmHg), measured in a seated position after rest according to standard procedures. Lower values indicate improved cardiovascular risk profile.

Other outcomes

  1. Exploratory Metabolic and Inflammatory Markers

    Time frame: Change from baseline to within 7 days after the fifth massage session (5 weeks).

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Magnus Wijkman, PhD/MD

CONTACT

[email protected]

Peter Johansson, Professor/RN

CONTACT

[email protected]

460700896548

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

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.

Acronym: TOHCD-D

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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