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

Wu Shangling

Status: Not yet enrolling

Conditions: Diabetes; Low Muscle Mass

Treatments: Other: Education; Dietary Supplement: Placebo; Behavioral: Exercise; Dietary Supplement: HMB

Study type: Interventional

Funder types: Other

Identifiers

NCT07142941

exercise and/or HMB

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

---

120 participants in 4 patient groups, including a placebo group

HMB + Exercise

Experimental group

Description:

Participants were instructed to take active products including 3000 mg calcium-HMB per day, and allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week

Treatment:

Dietary Supplement: HMB

Behavioral: Exercise

Placebo + Exercise

Experimental group

Description:

Participants allocated to the exercise programs were provided 45 min of supervised sessions on 2 nonconsecutive days per week, and were instructed to take active products including equal in quality resistant dextrin per day

Treatment:

Dietary Supplement: Placebo

Behavioral: Exercise

HMB + Education

Experimental group

Description:

Participants were instructed to take active products including 3000 mg calcium-HMB per day, and were given health education and educational manuals.

Treatment:

Dietary Supplement: HMB

Other: Education

Placebo + Education

Placebo Comparator group

Description:

Participants were instructed to take active products including equal in quality resistant dextrin per day, and were given health education and educational manuals

Treatment:

Dietary Supplement: Placebo

Other: Education