Clinical Trial: The effect of endurance training on BMP4 as a mediator of Cardio-Ankle Vascular Index in women with type 2 diabetes with peripheral neuropathy: A randomized controlled trial (Japan)

Tokyo, Nov. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059908) titled 'The effect of endurance training on BMP4 as a mediator of Cardio-Ankle Vascular Index in women with type 2 diabetes with peripheral neuropathy: A randomized controlled trial' on Nov. 28.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Shahrood University Of Technology

Condition: Condition - women diabetic type2 Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - 1)Effect of endurance training on BMP-4 in type-2 diabetic Women with peripheral neuropathy. 2)Effect of endurance training on CAVI in type-2 diabetic Women with peripheral neuropathy. 3)Effect of endurance training on Blood sugar levels in type-2 diabetic Women with peripheral neuropathy. 4)Effect of endurance training on Insulin in type-2 diabetic Women with peripheral neuropathy. 5)Effect of endurance training on HOMA-IR in type-2 diabetic Women with peripheral neuropathy. 6)Effect of endurance training on Body fat percentage in type-2 diabetic Women with peripheral neuropathy. 7)Effect of endurance training on Systolic BP in type-2 diabetic Women with peripheral neuropathy. 8)Effect of endurance training on Diastolic BP in type-2 diabetic Women with peripheral neuropathy. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The intervention group will undergo 12 weeks of supervised aerobic endurance training (3 sessions/week, 60-75 min/session) on treadmills. Session structure will consist of: 1) warm-up (10 min brisk walking + dynamic stretching). 2) main aerobic phase (weeks 1-2: 20-25 min; weeks 3-6: 30-35 min; weeks 7-10: 35-40 min; weeks 11-12: 45 min). 3) intensity of 50-70% heart rate reserve (Karvonen formula) progressively increasing from 50-55% (weeks 1-4) to 60-65% (weeks 5-8) and then to 70% (weeks 9-12). 4) cool-down (5-10 min light walking + stretching). Interventions/Control_2 - control group(for a three-month research program): no treatment. Continue their former lifestyle.

Eligibility: Age-lower limit - 40 years-old = Gender - Female Key inclusion criteria - Inclusion criteria will be: postmenopausal status (>=12 months amenorrhea), T2DM diagnosed according to ADA criteria with stable HbA1c (7.0-9.0% for >=12 months), fasting plasma glucose >126 mg/dL, MNSI score >7, BMI 25-39.9 kg/m^2, sedentary lifestyle (=180/110 mmHg), cardiovascular event or revascularization in the past 12 months, active diabetic foot ulcer or Charcot arthropathy, severe neuropathy impairing safe exercise (MNSI >=10 or inability to walk 1.6 km), renal impairment (eGFR <45 mL/min/1.73 m^2), smoking, malignancy, thyroid disease or inflammatory disorders, and participation in a regular exercise or weight-loss program. Target Size - 38

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2024 Year 11 Month 29 Day Date of IRB - 2022 Year 12 Month 20 Day Anticipated trial start date - 2024 Year 12 Month 20 Day Last follow-up date - 2025 Year 03 Month 25 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068518

Disclaimer: Curated by HT Syndication.