Severe obesity and low muscle mass and function

Spanish National Registry of sarcopenic obesity in patients with severe obesity

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16638723

Enrollment

480

Registered

2024-06-19

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

Study of sarcopenia prevalence in patients with severe obesity Musculoskeletal Diseases

Interventions

Patients will be selected from the Endocrinology and Nutrition outpatient clinics of eight tertiary public reference hospitals in Spain for Obesity treatment. Once selected and after signing the infor

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men and women aged between 18 and 65 years 2. Diagnosis of obesity with a body mass index greater than or equal to 35 kg/m2 with associated comorbidities or BMI >40 kg/m2 3. Able to give informed consent

Exclusion criteria

Exclusion criteria: 1. Weight greater than 227kg (load capacity limit DXA Hologic-Horizon WI model) 2. End-stage renal disease 3. Liver cirrhosis more advanced than Child A 4. Congestive heart failure NYHA grade 3-4 5. Serious limitations of functional capacity that prevent moving to the vehicle with the densitometer 6. Pregnancy 7. History of previous bariatric surgery 8. Not capable of granting informed consent 9. Patient refusal to participate in the study

Design outcomes

Primary

Measure	Time frame
Prevalence of sarcopenic obesity in people with severe obesity followed in Endocrinology and Nutrition outpatient clinics in reference centers for obesity treatment in Spain measured using patient records at the end of the study	—

Secondary

Measure	Time frame
1. Muscle strength measured using hand dynamometry 12 months after surgery 2. Appendicular lean mass measured using bone density test (DXA) evaluation at baseline and 12 months after surgery 3. Muscle function measured using plasma myokine determinations at baseline and 12 months after surgery 4. Prevalence of T2DM (in percentage) defined as HbA1c = 6.5% or fasting glucose in two occasions >7 mmol/l or use of antidiabetic treatment measured using plasma analysis at baseline and 12 months after surgery 5. Prevalence of hypertension (in percentage) defined as systolic and diastolic blood pressure = 140/90 or treatment with antihypertensive drugs measured using sphygmomanometer at baseline and 12 months after surgery 6. Prevalence of dyslipidemia defined as total cholesterol >200 mmol/l, LDL cholesterol >130 mmol/l or treatment with lipid-lowering treatment measured using plasma analysis at baseline and 12 months after surgery 7. Prevalence of obstructive sleep apnea defined as apnea-hypopnea index = 5 events/hour with OSA symptoms or = 15 events/hour without OSA symptoms measured using polysomnography at baseline and 12 months after surgery 8. Quality of life measured using the IWQOL-Lite test at baseline and 12 months after surgery 9. Physical activity performance measured using the Rapid Assessment of Physical Activity (RAPA) questionnaire at baseline and 12 months after surgery 10. Glucose control using HbA1c [measured using plasma analysis ] at baseline and 12 months after surgery 11. Insulin resistance using HOMA measurements at baseline and 12 months after surgery 12. Lipid profile using total and LDL cholesterol measurements in the laboratory at baseline and 12 months after surgery 13. Sarcopenia prevalence (in percentage) according to surgical treatments (Sleeve gastrectomy, gastric bypass, duodenal switch/SADI-S) measured using data collected from DXA evaluation 12 months after surgery 14. Surgical complications measured using the Clavien-Dindo classification	—

Measure

Time frame

1. Muscle strength measured using hand dynamometry 12 months after surgery 2. Appendicular lean mass measured using bone density test (DXA) evaluation at baseline and 12 months after surgery 3. Muscle function measured using plasma myokine determinations at baseline and 12 months after surgery 4. Prevalence of T2DM (in percentage) defined as HbA1c = 6.5% or fasting glucose in two occasions >7 mmol/l or use of antidiabetic treatment measured using plasma analysis at baseline and 12 months after surgery 5. Prevalence of hypertension (in percentage) defined as systolic and diastolic blood pressure = 140/90 or treatment with antihypertensive drugs measured using sphygmomanometer at baseline and 12 months after surgery 6. Prevalence of dyslipidemia defined as total cholesterol >200 mmol/l, LDL cholesterol >130 mmol/l or treatment with lipid-lowering treatment measured using plasma analysis at baseline and 12 months after surgery 7. Prevalence of obstructive sleep apnea defined as apnea-hypopnea index = 5 events/hour with OSA symptoms or = 15 events/hour without OSA symptoms measured using polysomnography at baseline and 12 months after surgery 8. Quality of life measured using the IWQOL-Lite test at baseline and 12 months after surgery 9. Physical activity performance measured using the Rapid Assessment of Physical Activity (RAPA) questionnaire at baseline and 12 months after surgery 10. Glucose control using HbA1c [measured using plasma analysis ] at baseline and 12 months after surgery 11. Insulin resistance using HOMA measurements at baseline and 12 months after surgery 12. Lipid profile using total and LDL cholesterol measurements in the laboratory at baseline and 12 months after surgery 13. Sarcopenia prevalence (in percentage) according to surgical treatments (Sleeve gastrectomy, gastric bypass, duodenal switch/SADI-S) measured using data collected from DXA evaluation 12 months after surgery 14. Surgical complications measured using the Clavien-Dindo classification

—

Countries

Spain

Contacts

Public ContactNuria Vilarrasa

nuriag@bellvitgehospital.cat+34 655492074

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026