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Sarcomeal oral supplement in treating diabetic sarcopenia

Investigating the effect of Sarcomeal oral supplementation and vitamin D3 on muscle parameters and metabolic factors in patients with diabetic sarcopenia: a randomized open-label clinical trial with parallel groups

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20230831059311N1
Enrollment
60
Registered
2024-01-29
Start date
2024-04-08
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic sarcopenia. Muscle wasting and atrophy, not elsewhere classified

Interventions

Intervention 1: Intervention group: Sarcomeal and vitamin D supplement consuming group. The people of the intervention group dissolve one sachet of Sarcomeal (content of one sachet is 38 grams) in a g

Sponsors

Tehran University of Medical Sciences
Lead Sponsor
Karen Pharmaceutical Company
Collaborator

Eligibility

Sex/Gender
All
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: At least a history of 6 months of type 2 diabetes confirmed by a specialist doctor Diagnosis of sarcopenia according to the criteria mentioned in the study method Signing a written consent to participate in the study Not using other supplements Absence of severe hepatic or renal disorder Absence of cancer

Exclusion criteria

Exclusion criteria: Existence of musculoskeletal disorders (back pain, knee pain, etc.) that lead to impaired walking The existence of comorbid orthopedic and neurological problems such as stroke, cerebral palsy, poliomyelitis, rheumatoid arthritis, and prosthesis The patient's unwillingness to cooperate Occurrence of any unforeseen problems in patients Not using more than 10% of supplements given in each follow-up

Design outcomes

Primary

MeasureTime frame
Muscle mass index (muscle mass of 4 organs per height squared). Timepoint: Twice with an interval of 12 weeks. Method of measurement: DEXA (dual x-ray absorptiometry).

Secondary

MeasureTime frame
Blood sugar. Timepoint: Twice with an interval of 12 weeks. Method of measurement: Blood test.;Inflammatory markers. Timepoint: Twice with an interval of 12 weeks. Method of measurement: Blood test.;Lipid profile. Timepoint: Twice with an interval of 12 weeks. Method of measurement: Blood test.;Vitamin D. Timepoint: Twice with an interval of 12 weeks. Method of measurement: Blood test.;Walking speed (the person's usual walking speed). Timepoint: Twice 12 weeks apart. Method of measurement: stopwatch.;Muscle strength (maximum muscle strength of both arms). Timepoint: Twice 12 weeks apart. Method of measurement: Dynamometer device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRamin Abdi Dezfouli

Tehran University of Medical Sciences

Raminabdi77@gmail.com+98 21 8863 1298

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026