Health TrialsbyHealthPanel

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

ConditionsDiabetesLow Muscle Mass
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-80
SponsorWu Shangling

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Factorial

Treatments tested in this trial

  • HMB

    Dietary supplement

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

  • Exercise

    Behavioral

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

  • Placebo

    Dietary supplement

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

  • Education

    Other intervention

    Participants were given health education and educational manuals

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: HMB + ExerciseExperimental treatment 2 interventions
Group B: Placebo + ExerciseExperimental treatment 2 interventions
Group C: HMB + EducationExperimental treatment 2 interventions
Group D: Placebo + EducationPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

muscle mass

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

Time frame
0 and 12 weeks
2

Handgrip strength

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

Time frame
0 and 12 weeks
3

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

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wu Shangling

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: