Therapeutic Outcomes of Using Complementary Hand-based Treatment in Diabetes

NCT07275086 | Not Yet Recruiting

• 1 other identifier: 2025-05625
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (10)

• 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.

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

• 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.

  Baseline and within 7 days after final massage (5 weeks).

• 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

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

• 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 from baseline to within 7 days after the fifth massage session (5 weeks).

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

  Limited efficacy outcome assessing preliminary within-group changes in glycemic control. Mean interstitial glucose derived from CGM. Lower values indicate improved glycemic control.

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

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

  Limited efficacy outcome assessing preliminary within-group changes in glycemic stability. Lower %CV indicates more stable glucose levels.

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

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

  Limited efficacy outcome assessing preliminary within-group glycemic control. Higher percentages indicate improved glucose regulation.

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

• Score on the Perceived Stress Scale-10 (PSS-10)

  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.

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

• Score on the Generalized Anxiety Disorder-7 (GAD-7)

  Limited efficacy outcome assessing preliminary within-group psychological changes. The GAD-7 ranges 0-21, with higher scores indicating more severe anxiety.

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

• Concentration of fasting plasma glucose (mmol/L)

  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.

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

Secondary Outcomes (2)

• 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).

Other Outcomes (1)

• Exploratory Metabolic and Inflammatory Markers

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

Study Arms (1)

Swedish Massage

EXPERIMENTAL

Participants receive Swedish massage once weekly for five consecutive weeks. Each session lasts 45-60 minutes and is delivered by a licensed massage therapist. Techniques include kneading, gliding, and tapping of soft tissues, focusing on the back, shoulders, and neck. The massage is designed to promote relaxation and modulate stress-related biological systems

Behavioral: Swedish massage

Interventions

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.

Swedish Massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Linkoeping University: collaborator
• University Hospital, Linkoeping: lead

Study Sites (1)

Peter Johansson

Norrköping, Linköpings Universitet, 601 74, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Peter Johansson, Professor/RN

CONTACT

460700896548; peter.b.johansson@liu.se

Magnus Wijkman, PhD/MD

CONTACT

magnus.wijkman@liu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label single-group pilot study; neither participants nor investigators are blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants receive Swedish massage once weekly for five weeks. Pre-post within-group design to explore biological and psychological effects and study feasibility.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 10, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)