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NCT Number: NCT06576518

Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study

INTRODUCTION: Obesity (OB) and metabolic syndrome (MetS) are risk and progression factors for chronic kidney disease (CKD). However, the effect of OB/MetS intervention with exercise on renal function progression and proteinuria is unknown.

OBJECTIVE: To analyse the effect of therapeutic exercise on MetS and main renal outcomes in patients with CKD.

METHODOLOGY: This is a 6-month prospective exploratory study. Patients with stablished CKD (1-4) and MetS were treated with individualised incremental exercise (aerobic and resistance). Simultaneously, a plan of adherence was set up to promote compliance. Renal and metabolic outcomes were collected. The main renal parameters were: proteinuria, in isolated urine samples, and glomerular filtration rate (GFR), measured by iohexol DBS, at 0, 3 and 6 months. At the same time points, metabolic outcomes were measured: weight, dyslipidemia, insulin resistance and hypertension.

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Key information

Conditions

Metabolic Syndrome Body Weight CKD Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de La Laguna

San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age >18 years
  • CKD of diverse aetiologies
  • estimated GFR ≥ 30 ml/min
  • BMI ≥ 27 kg/m2 associated to MetS or diabetes mellitus (DM)
  • stable renal function for at least 6 months before screening
  • ability to perform exercise

Exclusion criteria

  • clinical conditions that exclude exercise therapy such as clinical instability, active infection, cancer, acute cardiovascular disease, advanced CKD, pulmonary hypertension, or limb amputations
  • inability to understand the protocol
  • severe psychiatric illness
  • allergy to iodine

Treatment and study plan

Therapeutic exercise

Other

An individualised incremental exercise programme was simultaneously supported by an adherence plan to assess and promote compliance.

Primary outcomes

  1. Changes in Glomerular filtration rate (GFR) and urine abulmin-creatinine ratio (UACR).

    Time frame: Baseline, 3 and 6 months

    GFR and UACR were measured at baseline, 3 and 6 months, with the gold standard method of plasma clearance of iohexol (DBS technique) and urine analysis (isolated urine samples), respectively. The researchers expect a change in terms of GFR (improvement of hyperfiltration) and UACR reduction compared to baseline.

Secondary outcomes

  1. Changes in body weight and MetS traits (Analytics).

    Time frame: Baseline, month 3 and 6.

    Monthly, weight in kilograms, height in meters, waist circumference, hip circumference, will be measured. Also, BMI Body mass index (BMI): weight in kilograms divided by the square of the height in meters.Weight changes >5% were expected at 6 months.

    Changes in Mets traits as a relative change from baseline (%) or as success in falling below the cut-off point of the MetS definition. To evaluate the improvements in metabolic risk factors profile: obesity, triglycerides, blood pressure and HDL cholesterol.hemogram (hematocrit, haemoglobin, white blood count), biochemist tests: creatinine, HbA1c, total, LDL and HDL cholesterol, triglycerides, uric acid, hepatic enzymes (ASAT, ALAT), levels of immunosuppression, albumin, creatinine, albuminuria, proteinuria in an isolated urinary samples.

  2. Compliance-adherence

    Time frame: Monthly

    To ensure compliance, the following measures will be implemented: (a) contact by phone one time per week, (b) individual interview every month to reinforce lifestyle changes and follow all recommended in the exercise prescription; (c) the use of a gadget (xiaomi mi band) to see daily routines of patients and every training prescription, analysing the time, frequency, burned calories, velocity and distance, among others, to reach the established goal prescribed by the physiotherapist.

Sponsors and collaborators

Lead sponsor

University of La Laguna

Other

Collaborators

  • Fundación Canaria Instituto de Investigación Sanitaria de Canarias

Registry information

Official study title

Exercise Intervention in Patients With Metabolic Syndrome and Renal Disease: a Prospective Study (EXRED)

Acronym: EXRED

Important dates

Study start
2021
Primary completion
2021
Study completion
2024
First posted
Aug 28, 2024
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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