Nutrition Impact on PRGF Treatment for Tendinopathy

NCT06536582 | Recruiting

• 3 other identifiers: NUTRITENDON5xmille 2021CUPC43C2200237000L1054 Ricerca corrente
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Given the close correlation reported in the literature between onset and progression of tendon pathology in subjects affected by the alteration of metabolic disorders such as obesity, diabetes mellitus and lipidic metabolic alterations, with the present study the association between the nutritional state, metabolic profile and clinical outcome of patients following treatment with blood-derived orthobiological for shoulder tendinopathies will be evaluated. The primary aim of this study is to identify the proportion of tendinopatic patients responsive and non-responsive to treatment with "Platelet rich growth factors" PRGF at six months follow up and the correlation with their nutritional status.

Conditions

Shoulder Tendinopathy; Metabolic Alterations

Keywords

nutritional status; responder and non-responder patients; orthobiologics; Platelet rich growth factors

Outcome Measures

Primary Outcomes (29)

• Responder and non-responder patient identification at 6 months follow-up.

  The primary objective of this study is to identify the proportion of responder and non-responder patients with shoulder tendinopathy to treatment with orthobiological "Platelet rich growth factors" PRGF at six month follow up. Responsive and non-responsive patients will be identified on the basis of the results of the VAS, ASES, Quick Dash, SPADI, WOOS scores, and Work index.

  0-24 months

• Identification of nutritional status of responder and non-responder patients: complete blood count

  Complete blood count (cell number/dl)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: blood glucose

  Blood glucose (mg/dl)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: Hemoglobin A1C (HbA1c)

  Hemoglobin A1C (HbA1c): mmol/mol

  0-24 months

• Identification of nutritional status of responder and non-responder patients: urea

  Urea: mg/dl

  0-24 months

• Identification of nutritional status of responder and non-responder patients: creatinine

  Creatinine: mg/dl

  0-24 months

• Identification of nutritional status of responder and non-responder patients: siderosis

  siderosis: ug/dl

  0-24 months

• Identification of nutritional status of responder and non-responder patients: tryglicerides

  tryglicerides (mg/dl)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: cholesterol

  Cholesterol (mg/dl)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: Cholesterol HDL

  Cholesterol HDL (mg/dl)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: Glutamate-oxaloacetate transaminase

  Glutamate-oxaloacetate transaminase: (U/l)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: Glutamate-pyruvate transaminase

  Glutamate-pyruvate transaminase: (U/l)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: gamma GT

  Gamma GT: U/l

  0-24 months

• Identification of nutritional status of responder and non-responder patients: calcium

  Calcium: mg/dl

  0-24 months

• Identification of nutritional status of responder and non-responder patients: Vitamin D (25 OH)

  Vitamin D (25 OH): ng/ml

  0-24 months

• Identification of nutritional status of responder and non-responder patients: ferritin

  Ferritin (ng/ml)

  0-24 months

• Identification of nutritional status of responder and non-responder patients:

  C reactive protein: (mg/dl)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: thyroid stimulating hormone (TSH)

  thyroid stimulating hormone (TSH): uIU/ml

  0-24 months

• Identification of nutritional status of responder and non-responder patients: Insulin

  Insulin: uU/ml

  0-24 months

• Identification of nutritional status of responder and non-responder patients: Folates

  Folates (ng/ml)

  0-24 months

• Identification of nutritional status of responder and non-responder patients: vitamin B 12

  Vitamin B 12 (pg/ml)

  0-24 months

• Anthropometric measurement: weight

  weight (kg) measurement

  0-24 months

• Anthropometric measurement: height

  height (m) measurement

  0-24 months

• Anthropometric measurement: waist circumference

  waist circumference (cm) measurement

  0-24 months

• Anthropometric measurement: arm circumference measurements

  arm circumference measurements (cm)

  0-24 months

• Anthropometric measurement: biceps folds measurement

  biceps folds measurement (mm)

  0-24 months

• Anthropometric measurement: triceps folds measurement

  triceps folds measurement (mm)

  0-24 months

• Anthropometric measurement: subscapular folds measurement

  subscapular folds measurement (mm)

  0-24 months

• Anthropometric measurement: suprailiac folds measurement

  suprailiac folds measurement (mm)

  0-24 months

Secondary Outcomes (8)

• Responder and non-responder patient identification at 2 months follow-up.

  2-26 months

• Responder and non-responder patient identification at 12 months follow-up.

  12-36 months

• The Platelet rich growth factors "PRGF" product used for the treatment of each patient will be characterizated: extracellular vesicles count

  24-26 months

• The PRGF product used for the treatment of each patient will be characterizated: extracellular vesicles marker quantification

  24-26 months

• The PRGF product used for the treatment of each patient will be characterizated- quantitative analysis of cytokines: CXCL8

  24-26 months

Other Outcomes (6)

• VAS

  2-36 months

• ASES SCORE

  2-36 months

• Quick Dash Score

  2-36 months

Study Arms (2)

Normal weight patients

23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF.

Biological: Platelet rich growth factor injection (autologous product)

Over weight patients

23 subjects with BMI values that exceed the considered range normal weight, therefore with BMI\>25, who undergo the PRGF treatment

Biological: Platelet rich growth factor injection (autologous product)

Interventions

Platelet rich growth factor injection (autologous product) BIOLOGICAL

All patients will undergo two PRGF injections, one at recruitment and one 14 days after the first injection. The injection site will be the shoulder with tendinopathy.

Normal weight patients; Over weight patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male and female patients, between 18 and 70 years old suffering from shoulder tendinopathy undergoing a conservative regenerative medicine procedure with autologous PRGF at the IRCCS Galeazzi-Sant'Ambrogio Hospital of Milan and participants at the observational study "Use of patients- Reported Outcome Measures (PROM), objective clinical assessments and biomolecular technologies for monitoring patients undergoing treatments regenerative medicine" \[REGAIN\] will be enrolled for this study. 46 patients will be needed: 1. 23 subjects with body mass index (BMI) between 18.5 and 25 therefore considered normal weight, who undergo treatment with PRGF; 2. 23 subjects with BMI values that exceed the considered range normal weight, therefore with BMI\>25, who undergo the PRGF treatment.

You may qualify if:

• Male and female
• Age ≥18 years and ≤ 70 years
• Patients presenting shoulder tendinopathy
• Signing of the Informed Consent of the Regain observational study
• Signature of informed consent of the present study.

You may not qualify if:

• Pregnancy (ascertained by self-declaration), breastfeeding
• Inability to follow the study protocol
• Heart, kidney, oncological disease
• Neuropsychiatric disease
• Other conditions that, at the discretion of the investigator or physician, exclude enrollement

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Milan, 20173, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

human blood samples

Central Study Contacts

Paola De Luca, PhD

CONTACT

+39 3921385179; deluca.paola@grupposandonato.it

Michela Taiana, PhD

CONTACT

+39 3335952857; michelamaria.taiana@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: August 5, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): February 15, 2027
• Last Updated: August 5, 2024

Record last verified: 2024-07

Locations

IT (1)