Exercise and/or HMB in Older Diabetes With Low Muscle Mass

N/ANot Yet RecruitingNCT07142941

Wu Shangling120 enrolled

Overview

The investigators aimed to examine if β-hydroxy-β-methylbutyrate (HMB) supplementation enhances the effects of exercise on muscle mass, physical performance and insulin resistance and observe potential residual effects in older diabetes with low muscle mass, and to find the optimal treatment plan.

The interaction between exercise and nutritional supplementation is unclear among older diabetes at risk of sarcopenia. The investigators aimed to examine if β-hydroxy-β-methylbutyrate (HMB) supplementation enhances the effects of exercise on muscle mass, physical performance and insulin resistance and observe potential residual effects in older diabetes with low muscle mass, and to find the optimal treatment plan. This 12-wk, randomized, double-blind, placebo controlled, 2 × 2 factorial design (exercise-only, HMB-only, both, and none) trial included 120 older diabetes aged 60-80 y with skeletal muscle index \<5.7 kg/m2 for women, and \<7.0 kg/m2 for men, and was followed by a 12-wk observational period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Diabetes Low Muscle Mass

Interventions

HMBDIETARY_SUPPLEMENT

Participants were instructed to take active products including 3000 mg calcium-HMB per day

ExerciseBEHAVIORAL

Participants allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week

PlaceboDIETARY_SUPPLEMENT

Participants were instructed to take active products including equal in quality resistant dextrin per day

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 60-80 ; * Diagnosis of T2DM * Low muscle mass: met a reference value for low muscle mass defined by the Asian Working Group for Sarcopenia (AWGS) criteria with skeletal muscle index \<5.7 kg/m2 for women and \<7.0 kg/m2 for men Exclusion Criteria: * Individuals who had an organic disease of the nervous system; * Who were restricted from engaging in exercise by a medical doctor; * Who was unconscious and unable to complete the questionnaire; * Who used other supplementations for muscle mass gain; * Who had impaired cardiac, kidney, or liver function.

Outcomes

Primary Outcomes

muscle mass

Body composition including muscle mass was measured using a segmental multifrequency bioelectrical impedance device (Inbody)

Time frame: 0 and 12 weeks

Handgrip strength

Handgrip strength was measured using a handheld Smedley-type dynamometer.

Time frame: 0 and 12 weeks

5-repetition sit-to-stand time

Participants folded their arms across their chests and were instructed to stand-up completely and make firm contact when sitting. Timing began on the command "go" and ceased when the participants sat after the fifth stand-up. Participants were allowed a practice trial of 2 repetitions before the timing of 2 test trials of 5 repetitions.

Time frame: 0 and 12 weeks

Secondary Outcomes

insulin resistance index

Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) was calculated as follow: HOMA-IR=(Fasting Insulin (μU/mL)×Fasting Glucose (mg/dL))/405

Time frame: 0 and 12 weeks

Central Contacts

Shangling Wu

CONTACT

(020)87338179 wushling6@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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