NCT07659925

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress43%
May 2026Dec 2026

Study Start

First participant enrolled

May 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 6, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

Type 2 Diabetes MellitusStrength TrainingNon-linear PeriodizationExercise CapacityMuscle StrengthQuality of LifeLinear PeriodizationResistance Training

Outcome Measures

Primary Outcomes (1)

  • Exercise Capacity

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

    Baseline and after 8 week

Secondary Outcomes (8)

  • Change in Peripheral Muscle Strength

    Baseline and after 8 weeks

  • Change in Hand Grip Strength

    Baseline and after 8 weeks

  • Change in Diabetes Quality of Life Questionnaire Score

    Baseline and after 8 weeks

  • Change in Body Fat Percentage

    Baseline and after 8 weeks

  • Change in Skeletal Muscle Mass

    Baseline and after 8 weeks

  • +3 more secondary outcomes

Study Arms (3)

Non-linear Periodization Group

EXPERIMENTAL

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

Behavioral: Non-linear Periodization-Based Strength Training

Linear Periodization Group

EXPERIMENTAL

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

Behavioral: Linear Periodization-Based Strength Training

Control Group

ACTIVE COMPARATOR

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

Other: Usual Care

Interventions

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

Non-linear Periodization Group

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

Linear Periodization Group

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

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Hospital

Ankara, Ankara, 06790, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Neslihan Duruturk, PhD

    Baskent University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayşegül Erkoç, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to one of three parallel groups: non-linear periodization-based strength training, linear periodization-based strength training, or control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 22, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations