Exercise and PPARGC1A rs8192678 in Older Adults With Type 2 Diabetes and Cognitive Impairment

NCT07711834 | Completed

• 1 other identifier: HSU-2025115-PPARGC1A-T2DMCI
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This completed single-arm interventional study evaluated changes in metabolic control, cognitive function, and health-related physical fitness following a 12-week combined aerobic and resistance exercise program in older adults with type 2 diabetes mellitus and cognitive impairment. The study also explored whether the magnitude of response to exercise differed according to PPARGC1A rs8192678 genotype. A total of 75 participants were genotyped, and 45 participants were included in a balanced genotype-stratified cohort, consisting of 15 participants with the CC genotype, 15 with the CT genotype, and 15 with the TT genotype. All participants received the same exercise intervention and were assessed at baseline and at Week 12.

Conditions

Type 2 Diabetes Mellitus (T2DM); Cognitive Impairment

Keywords

Older; adults; Type 2 diabetes mellitus; Cognitive impairment; Exercise intervention; Aerobic exercise; Resistance exercise; PPARGC1A; rs8192678; Genetic polymorphism; Glycolipid metabolism; Montreal Cognitive Assessment; Health-related physical fitness

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Glycated Hemoglobin at 12 Weeks

  Change in glycated hemoglobin percentage from baseline to the end of the 12-week exercise intervention.

  Baseline and 12 weeks

• Change From Baseline in Fasting Plasma Glucose at 12 Weeks

  Change in fasting plasma glucose concentration from baseline to the end of the 12-week exercise intervention.

  Baseline and 12 weeks

• Change From Baseline in Montreal Cognitive Assessment Total Score at 12 Weeks

  Global cognitive function was assessed using the Montreal Cognitive Assessment (MoCA). The instrument contains 12 tasks covering eight cognitive domains. The total score is reported on a scale ranging from 0 to 30 points. In accordance with the study protocol, 1 point was added for participants with 12 or fewer years of education. Higher scores indicate better cognitive function. Change from baseline was calculated as the Week 12 score minus the baseline score; a positive change indicates improvement in cognitive function.

  Baseline and 12 weeks

Secondary Outcomes (15)

• Change From Baseline in Fasting Insulin at 12 Weeks

  Baseline and 12 weeks

• Change From Baseline in Total Cholesterol at 12 Weeks

  Baseline and 12 weeks

• Change From Baseline in Triglycerides at 12 Weeks

  Baseline and 12 weeks

• Change From Baseline in High-Density Lipoprotein Cholesterol at 12 Weeks

  Baseline and 12 weeks

• Change From Baseline in Low-Density Lipoprotein Cholesterol at 12 Weeks

  Baseline and 12 weeks

Study Arms (1)

Combined Aerobic and Resistance Exercise

EXPERIMENTAL

Participants received a 12-week combined aerobic and resistance exercise program, including aerobic exercise four times per week and elastic-band resistance exercise twice per week. Exercise intensity and duration were progressively increased during the intervention.

Behavioral: Combined aerobic and resistance exercise

Interventions

Combined aerobic and resistance exercise BEHAVIORAL

A 12-week combined exercise program including aerobics and elastic-band resistance training. Aerobic exercise was performed four times per week, with intensity progressing from 50%-60% HRmax during weeks 1-6 to 60%-70% HRmax during weeks 7-12. Resistance exercise was performed twice per week using elastic bands, with intensity progressing from 40%-50% 1RM during weeks 1-6 to 50%-60% 1RM during weeks 7-12. Exercise duration gradually increased from 20 minutes to 40 minutes.

Combined Aerobic and Resistance Exercise

Eligibility Criteria

• Age: 65 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosed with type 2 diabetes mellitus.
• No regular exercise training during the previous six months.
• Aged 65 to 79 years.
• Self-reported memory decline and Montreal Cognitive Assessment score \<26.
• Stable antidiabetic medication use and stable dietary control.
• Participant or family member provided informed consent.

You may not qualify if:

• Diabetic ketoacidosis within the previous three months.
• Visual or hearing impairment or other conditions affecting cognitive assessment.
• Fracture, limb disability, or other motor disorders affecting exercise participation.
• History of psychiatric disorders.
• History of stroke, brain tumor, hypothyroidism, or other diseases that may affect cognitive function.
• Poor compliance or failure to follow the prescribed diet or exercise requirements.

Sponsors & Collaborators

• Harbin Sport University: lead

Study Sites (1)

Harbin Sport University

Harbin, Heilongjiang, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Nijia Meng, Associate Professor

  Harbin Sport University

  PRINCIPAL INVESTIGATOR

• Xichao Zhang

  Harbin Sport University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was used because this was an exercise intervention study and all participants received the same intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants received the same 12-week combined aerobic and resistance exercise intervention. Participants were stratified by PPARGC1A rs8192678 genotype for subgroup analysis, but genotype subgroups were not separate intervention arms.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 17, 2026
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (1)