Exercise and PPARGC1A rs8192678 in Older Adults With Type 2 Diabetes and Cognitive Impairment (Association Be)
Association Between PPARGC1A rs8192678 Polymorphism and the Effects of a 12-Week Combined Aerobic and Resistance Exercise Intervention in Older Adults With Type 2 Diabetes Mellitus and Cognitive Impairment
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.
調査の概要
詳細な説明
This was a completed, retrospectively registered, single-arm exercise intervention study with prespecified genotype-stratified analyses. The study examined whether PPARGC1A rs8192678 genotype was associated with interindividual variation in response to a standardized combined aerobic and resistance exercise program in older adults with type 2 diabetes mellitus and cognitive impairment.
PPARGC1A rs8192678 genotyping was performed on peripheral blood DNA using Kompetitive Allele-Specific Polymerase Chain Reaction (KASP). Genotype was used as an analytical stratification factor and did not determine intervention assignment. From 75 genotyped participants, a balanced cohort of 45 participants was included, comprising 15 participants with each of the CC, CT, and TT genotypes.
All participants received the same 12-week exercise intervention. Aerobic exercise consisted of group-based aerobics performed four times per week. Aerobic exercise duration progressed from 20 minutes per session during Weeks 1-4 to 30 minutes during Weeks 5-8 and 40 minutes during Weeks 9-12. Exercise intensity progressed from 50%-60% of age-predicted maximum heart rate during Weeks 1-6 to 60%-70% during Weeks 7-12. Maximum heart rate was estimated using the equation: 207 - 0.7 × age.
Resistance exercise using elastic bands was performed twice per week. Resistance exercise duration progressed from 20 minutes during Weeks 1-4 to 30 minutes during Weeks 5-8 and 40 minutes during Weeks 9-12. Intensity progressed from 40%-50% of estimated one-repetition maximum during Weeks 1-6 to 50%-60% during Weeks 7-12. One-repetition maximum was estimated from a 10-15 repetition-maximum test using the Brzycki equation: estimated 1RM = load/[1.0278 - (0.0278 × number of repetitions)].
Exercise sessions included a 5-10-minute warm-up and cool-down period. Heart-rate monitors, supervised instruction, standardized exercise demonstrations, and safety monitoring were used to maintain the prescribed intensity and intervention quality. Measurements were obtained before the intervention and after 12 weeks. The main analysis assessed within-participant change from baseline, and exploratory analyses compared changes among genotype groups. For variables with significant baseline differences, analysis of covariance was performed using the baseline value as a covariate.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Heilongjiang
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Harbin、Heilongjiang、中国
- Harbin Sport University
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参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Combined Aerobic and Resistance Exercise
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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change From Baseline in Glycated Hemoglobin at 12 Weeks
時間枠：Baseline and 12 weeks
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Change in glycated hemoglobin percentage from baseline to the end of the 12-week exercise intervention.
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Baseline and 12 weeks
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Change From Baseline in Fasting Plasma Glucose at 12 Weeks
時間枠：Baseline and 12 weeks
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Change in fasting plasma glucose concentration from baseline to the end of the 12-week exercise intervention.
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Baseline and 12 weeks
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Change From Baseline in Montreal Cognitive Assessment Total Score at 12 Weeks
時間枠：Baseline and 12 weeks
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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.
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Baseline and 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change From Baseline in Fasting Insulin at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Total Cholesterol at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Triglycerides at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in High-Density Lipoprotein Cholesterol at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Low-Density Lipoprotein Cholesterol at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Body Weight at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Muscle Mass at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Body Mass Index at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Body Fat Percentage at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Vital Capacity Measured Using a GMCS-FHL3 Vital Capacity Tester at 12 Weeks
時間枠：Baseline and 12 weeks
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Vital capacity was measured in milliliters using a GMCS-FHL3 vital capacity tester manufactured by Beijing Xindong Huateng Sports Equipment Co., Ltd.
Participants were tested in a standing position.
After taking several deep breaths, each participant inhaled maximally and then exhaled continuously and completely through the mouthpiece without taking an additional breath.
Two trials were performed, and the highest recorded value was used for analysis.
Higher values indicate better respiratory function.
Change from baseline was calculated as the Week 12 value minus the baseline value; a positive change indicates improvement.
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Baseline and 12 weeks
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Change From Baseline in Relative Handgrip Strength, Calculated as Maximum Handgrip Strength Divided by Body Weight, at 12 Weeks
時間枠：Baseline and 12 weeks
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Maximum handgrip strength was measured in kilograms using a GMCS-WCS3 digital handgrip dynamometer manufactured by Beijing Xindong Huateng Sports Equipment Co., Ltd. Participants were assessed while standing upright with the tested arm naturally extended beside the body without touching the trunk. Each hand was tested twice, and the highest value obtained across the four trials was used. Relative handgrip strength was calculated as maximum handgrip strength in kilograms divided by body weight in kilograms and was reported as a dimensionless kg/kg ratio. This is a continuous physiological ratio rather than a bounded questionnaire scale. Its theoretical minimum is 0, and it has no fixed maximum. Higher values indicate greater handgrip strength relative to body weight. Change from baseline was calculated as the Week 12 ratio minus the baseline ratio; a positive change indicates improvement. |
Baseline and 12 weeks
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Change From Baseline in Sit-and-Reach Performance at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in 30-Second Sit-to-Stand Performance at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in One-Legged Standing With Eyes Closed at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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Change From Baseline in Choice Reaction Time at 12 Weeks
時間枠：Baseline and 12 weeks
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Baseline and 12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Nijia Meng, Associate Professor、Harbin Sport University
- スタディディレクター：Xichao Zhang、Harbin Sport University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。