Tokyo, Jan. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060249) titled 'Effects of Aerobic Exercise and Camel Milk Supplementation, Separately and Combined, on Glycemic Control in Postmenopausal Women with Type 2 Diabetes: A Randomized Controlled Trial' on Jan. 4.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -but assessor(s) are blinded
Control - No treatment
Primary Sponsor:
Institute - Department of Physical Education and Sport Sciences, Faculty of Physical Education, Shahrood University of Technology, Shahrood, Iran.
Condition:
Condition - women diabetic type2
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Effects of Aerobic Exercise and Camel Milk Supplementation, on Fasting Blood Sugar in Postmenopausal Women with Type 2 Diabetes.
Effects of Aerobic Exercise and Camel Milk Supplementation, on Hemoglobin A1c in Postmenopausal Women with Type 2 Diabetes.
Effects of Aerobic Exercise and Camel Milk Supplementation, on Insulin Resistance in Postmenopausal Women with Type 2 Diabetes.
Effects of Aerobic Exercise and Camel Milk Supplementation, on body composition in Postmenopausal Women with Type 2 Diabetes.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The intervention was conducted over 10 weeks. Group A (Camel Milk + Exercise) consumed 250 mL of fresh camel milk daily (sourced from local herds with veterinary approval) four days a week (on training days) while simultaneously performing aerobic exercise three sessions per week.
Interventions/Control_2 - Group B (Camel Milk Only) consumed 250 mL of fresh camel milk daily for 10 weeks.
Eligibility:
Age-lower limit - 40
years-old
=
Gender - Female
Key inclusion criteria - Inclusion criteria included natural menopause (12 months without menstruation), age 40 to 65 years, medical diagnosis of T2DM for at least 2 years, non-use of injectable insulin (oral treatment only), no regular physical activity in the past 6 months, non-smoker status, absence of orthopedic or mobility restrictions, and provision of written informed consent.
Key exclusion criteria - Exclusion criteria included having cardiovascular diseases, uncontrolled hypertension, kidney or liver failure, use of medications affecting glucose metabolism (other than standard diabetes drugs), non-adherence to the protocol (missing more than 2 training sessions or consuming less than 80% of the prescribed camel milk), and the occurrence of complications during the intervention (such as severe hypoglycemia or muscle injury).
Target Size - 48
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2022 Year 11 Month 23 Day
Date of IRB - 2022 Year 12 Month 25 Day
Anticipated trial start date - 2024 Year 10 Month 06 Day
Last follow-up date - 2025 Year 01 Month 15 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068913
Disclaimer: Curated by HT Syndication.