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NCT Number: NCT07659925

Periodization-Based Strength Exercise Training in İndividuals With Type 2 Diabetes

This randomized controlled study aims to compare the effects of different periodization-based strength training approaches in individuals with type 2 diabetes mellitus. Participants will be allocated to non-linear periodization, linear periodization, or control groups. The intervention program will be conducted for 8 weeks and will evaluate exercise capacity, muscle strength, quality of life, body composition, and metabolic parameters.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Type 2 diabetes mellitus is associated with reduced exercise capacity, decreased muscle strength, impaired quality of life, and metabolic dysfunction. Exercise training is recommended as an important component of diabetes management; however, the comparative effectiveness of different strength training periodization approaches remains unclear.

This randomized controlled trial aims to compare the effects of non-linear periodization and linear periodization strength training programs in individuals with type 2 diabetes mellitus. Participants will be randomized into three groups: a non-linear periodization training group, a linear periodization training group, and a control group receiving usual care.

The intervention will be conducted for 8 weeks, three times per week. Outcomes including exercise capacity, muscle strength, body composition, quality of life, and metabolic parameters will be evaluated before and after the intervention period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged between 18 to 65 years
  • Diagnosis of Type 2 Diabetes Mellitus (T2DM)
  • Not having participated in any structured exercise program within the last 6 months
  • Willingness to participate in the study and provide written informed consent

Exclusion criteria

  • Presence of nephropathy, retinopathy, or peripheral neuropathy
  • Presence of neurological, cognitive, or orthopedic disorders that may affect outcome measurements
  • Severe respiratory disease (Forced Expiratory Volume in the first second [FEV1] <35% or Forced Vital Capacity [FVC] <50%)
  • Presence of ischemic heart disease or peripheral arterial disease
  • History of any cardiovascular event within the last 6 months
  • Current malignancy

Treatment and study plan

Non-linear Periodization-Based Strength Training

Behavioral

Participants will perform supervised non-linear periodization-based strength training three times per week for 8 weeks.

Linear Periodization-Based Strength Training

Behavioral

Participants will perform supervised linear periodization-based strength training three times per week for 8 weeks.

Usual Care

Other

Participants will receive usual care and no structured exercise intervention during the study period.

Primary outcomes

  1. Exercise Capacity

    Time frame: Baseline and after 8 week

    Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT)

Secondary outcomes

  1. Change in Peripheral Muscle Strength

    Time frame: Baseline and after 8 weeks

    Peripheral muscle strength will be assessed using handheld dynamometry for upper and lower extremity muscle groups and reported in Newton (N).

  2. Change in Hand Grip Strength

    Time frame: Baseline and after 8 weeks

    Hand grip strength will be assessed using a hand dynamometer and reported in kilograms (kg).

  3. Change in Diabetes Quality of Life Questionnaire Score

    Time frame: Baseline and after 8 weeks

    Change in the Turkish version of the Diabetes Quality of Life Questionnaire (DQOL) total score and subscale scores from baseline to 8 weeks will be evaluated. The DQOL consists of 45 items assessing treatment satisfaction, psychological impact, concerns about future effects of diabetes, and social/vocational concerns. Each item is scored on a 1-5 scale, and higher scores indicate better diabetes-related quality of life.

  4. Change in Body Fat Percentage

    Time frame: Baseline and after 8 weeks

    Body fat percentage (%) will be assessed using bioelectrical impedance analysis (BIA).

  5. Change in Skeletal Muscle Mass

    Time frame: Baseline and after 8 weeks

    Skeletal muscle mass (kg) will be assessed using bioelectrical impedance analysis (BIA).

  6. Change in Resting Metabolic Rate

    Time frame: Baseline and after 8 weeks

    Resting metabolic rate (kcal/day) will be assessed using indirect calorimetry (COSMED Fitmate Pro, Rome, Italy).

  7. Change in Hemoglobin A1c (HbA1c)

    Time frame: Baseline and after 8 weeks

    Glycemic control will be assessed by measuring glycated hemoglobin (HbA1c) levels (%).

  8. Change in Fasting Blood Glucose

    Time frame: Baseline and after 8 weeks

    Glycemic control will be assessed by measuring fasting blood glucose levels (mg/dL).

Study contacts

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

Ayşegül Erkoç, PT

CONTACT

[email protected]

+90 553-301-36-73

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

A Comparison of the Effects of Different Periodization-Based Strength Training Programs in Individuals With Type 2 Diabetes Mellitus

Acronym: T2DM_NLP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

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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