To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease With MRI

NCT04564924 | Unknown

• 1 other identifier: S094
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic kidney disease (CKD) have a higher risk of fractures than those without. The purpose of this study is to develop a non-invasive Magnetic resonance imaging (MRI) method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Outcome Measures

Primary Outcomes (15)

• Magnetic resonance examination for general diagnosis：routine imaging sequences

  All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.

  12 months

• Magnetic resonance examination to measure tissue diffusion and perfusion：DWI-related sequence

  All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence:Diffusion Weighted Imaging(DWI)-related sequence

  12 months

• Magnetic resonance examination to measure material changes in tissue：CEST

  All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence: chemical exchange saturation transfer(CEST)

  12 months

• Magnetic resonance examination to measure the fat content of tissues：IDEAL- IQ

  All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group.And the full abbreviation of the above sequence：iterative decomposition of water and fat with echo asymmetry and least-squares estimation (IDEAL) - intelligent quantification (IQ)

  12 months

• Magnetic resonance examination with ultrashort echo time to imaging musculoskeletal ：UTE

  All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lumbar spine and lower legs of both experimental group and control group. And the full abbreviation of the above sequence: ultrashort echo time (UTE)

  12 months

• Magnetic resonance examination for bone morphological observation: ZTE

  All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lower legs of both experimental group and control group.And the full abbreviation of the above sequence: Zero-Echo Time(ZTE)

  12 months

• Magnetic resonance examination to measure changes in the relaxation rate of muscles and blood vessels: SWI

  All MRI imaging was performed on a clinical 3.0 T General Electric(GE) MR scanner on the lower legs of both experimental group and control group. And the full abbreviation of the above sequence: Susceptibility-weighted Imaging(SWI)

  12 months

• Bone mineral density（BMD）measured by DXA

  The dual energy x-ray absorptiometry (DXA) was performed on the lumbar spine of both experimental group and control group.

  12 months

• Blood biochemistry ：Routine blood was used to detect anemia

  Routine blood samples were collected from individuals in the experimental group

  12 months

• Blood biochemistry ：renal function was used for staging CKD

  Renal function samples were collected from individuals in the experimental group and control group

  12 months

• Blood biochemistry ：Serum electrolyte was used to detect electrolyte changes

  Serum electrolyte samples were collected from individuals in the experimental group

  12 months

• Blood biochemistry ：the ALP、PTH、25-OH VitD、osteocalcin、T-P1NP and β-CTX were used to detect bone metabolism

  The above serum samples were collected from individuals in the experimental group

  12 months

• Blood biochemistry ： blood glucose was used to determine the presence or absence of diabetes

  Blood glucose samples were collected from individuals in the experimental group

  12 months

• Blood biochemistry ：CK(Creatine kinase) was used to detect muscle lesions

  CK samples were collected from individuals in the experimental group

  12 months

• The urine routine was examined to determine whether individuals in the control group and the experimental group had hematuria and proteinuria

  The Routine urine samples were collected from individuals in the experimental group and control group

  12 months

Study Arms (2)

MRI & DXA patients

No intervention

Radiation: DXA

MRI & DXA volunteers

No intervention

Radiation: DXA

Interventions

DXA RADIATION

Bone mineral density was examined in all cases and controls

MRI & DXA patients; MRI & DXA volunteers

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

Subject group:Hospitalized patients in department of Nephrology, Tongji Hospital, Qiaokou District, Wuhan, Hubei, China control group:social recruitment

You may qualify if:

• CKD patients aged 18-70 years with free movement

You may not qualify if:

• The following diseases: rickets, osteomalacia, Paget's disease, acromegaly, scurvy (vitamin C deficiency), hyperthyroidism, history of malignant tumors, received radiotherapy and chemotherapy, fractures within 6 months, lumbar and calf trauma surgery, scoliosis, rheumatic immunity disease, anorexia nervosa, motor neuron disease
• Treated with the following drugs within two years:
• A) Bisphosphonates: Alendronate , etidronate , Ibandronate, rithiadronate, and zoledronate B) Steroid hormones: estrogen replacement agents , isoflavone derivatives , estrogen, progesterone C) Oral glucocorticoids: prednisone , Prednisone D) Salmon calcitonin
• MRI contraindications: Intra Uterine Device(iUD), pacemaker, cochlear implant, claustrophobia, etc -

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine, serum

MeSH Terms

Conditions

Chronic Kidney Disease-Mineral and Bone Disorder

Condition Hierarchy (Ancestors)

Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

yan Xiong, PhD

CONTACT

15549460070; 313857231@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 25, 2020
• Study Start: September 2, 2020
• Primary Completion: September 30, 2021
• Study Completion: January 30, 2022
• Last Updated: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)