PreptinNCT06594042
Serum Preptin Level and Its Relationship With Bone Mineral Disease in Chronic Kidney Disease Patients
An observational study of Preptin, run by Assiut University.
Trial summary
Aim of the research:To identify preptin level and relationship with bone disease in chronic kidney disease patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Preptin
- What is being tested?
- serum preptin
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Adult
Study population: study setting : dialysis unit and outpatient clinic of nephrology study subjects: the study will include 96 participants dividing into three groups of patients control group, chronic kidney disease patients .
Who may be able to join
- both sex groups of patients with age between 18-50 years . pre end stage renal disease and end stage renal disease patients .
Who cannot join
- type 2 diabetic patients
Trial locations and contacts
No sites are listed yet.
About this study
Aim of the research:To identify preptin level and relationship with bone disease in chronic kidney disease patients.
Read the detailed description
Preptin is a 34-aminoacid peptide derived from the E-peptide of pro-insulin-like growth factor 2 (pro-IGF2) that is co-secreted with insulin and upregulates glucose-mediated insulin secretion. High serum preptin levels were described in conditions associated with insulin resistance, such as polycystic ovary syndrome and type 2 diabetes mellitus (T2M). Insulin and also IGF2 are known to be anabolic bone hormones .
Preptin stimulates osteoblastic proliferation and increases mineralization in a concentration-independent manner in osteoblast precursor cell , Despite being associated with insulin resistance, an increased fat mass has beneficial bone effects . While the increased mechanical loading favors bone formation, adipokines and also pancreatic and gut hormones were also proposed to mediate the relationship between fat and bone. The importance of nutritional hormones in maintaining bone mass was, thus, recognized. Insulin has anabolic bone effects, and hyperinsulinemia contributes to increased bone mineral density (BMD). Similar to insulin, insulin-like growth factor 1 (IGF1) and IGF2, preptin was recently proposed to have anabolic bone activity .
End-stage renal disease (ESRD) patients present with specific bone and mineral metabolism disturbances. Chronic kidney disease-associated mineral and bone disorder accounts for increased morbidity and mortality in those patients. Biochemical markers known thus far do not effectively predict the complex bone changes that are observed in ESRD patients .
- Conditions
- Preptin
- Being tested
- serum preptin
- Keywords
- chronic kidney preptin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum preptinDiagnostic test
serum preptin level in chronic kidney disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Preptin level and its relationship with bone mineral disease in chronic kidney disease patients
To identify preptin level and relationship with bone disease in chronic kidney disease patients.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startJun 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PreptinStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594042
- Sponsor's protocol ID
- preptin chronic kidney disease
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kaluzna M, Pawlaczyk K, Schwermer K, Hoppe K, Yusuf Ibrahim A, Czlapka-Matyasik M, Wrotkowska E, Ziemnicka K, Oko A, Ruchala M. Is Preptin a New Bone Metabolism Parameter in Hemodialysis Patients? Life (Basel). 2021 Apr 12;11(4):341. doi: 10.3390/life11040341.
PubMed 33921361Livingstone C, Borai A. Insulin-like growth factor-II: its role in metabolic and endocrine disease. Clin Endocrinol (Oxf). 2014 Jun;80(6):773-81. doi: 10.1111/cen.12446. Epub 2014 Mar 24.
PubMed 24593700Zhang M, Xuan S, Bouxsein ML, von Stechow D, Akeno N, Faugere MC, Malluche H, Zhao G, Rosen CJ, Efstratiadis A, Clemens TL. Osteoblast-specific knockout of the insulin-like growth factor (IGF) receptor gene reveals an essential role of IGF signaling in bone matrix mineralization. J Biol Chem. 2002 Nov 15;277(46):44005-12. doi: 10.1074/jbc.M208265200. Epub 2002 Sep 4.
PubMed 12215457Naot D, Cornish J. Cytokines and Hormones That Contribute to the Positive Association between Fat and Bone. Front Endocrinol (Lausanne). 2014 May 9;5:70. doi: 10.3389/fendo.2014.00070. eCollection 2014.
PubMed 24847313Reid IR. Fat and bone. Arch Biochem Biophys. 2010 Nov 1;503(1):20-7. doi: 10.1016/j.abb.2010.06.027. Epub 2010 Jul 3.
PubMed 20599663Xiao C, Li W, Lu T, Wang J, Han J. Preptin promotes proliferation and osteogenesis of MC3T3-E1 cells by upregulating beta-catenin expression. IUBMB Life. 2019 Jul;71(7):854-862. doi: 10.1002/iub.2016. Epub 2019 Feb 6.
PubMed 30729647Ungureanu MC, Bilha SC, Hogas M, Velicescu C, Leustean L, Teodoriu LC, Preda C. Preptin: A New Bone Metabolic Parameter? Metabolites. 2023 Sep 4;13(9):991. doi: 10.3390/metabo13090991.
PubMed 37755271
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Preptin Level and Its Relationship With Bone Mineral Disease in Chronic Kidney Disease Patients
- ClinicalTrials.gov ID
- NCT06594042
- Acronym / sponsor ID
- preptin chronic kidney disease
- Conditions
- Preptin
- Keywords
- chronic kidney preptin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of the research:To identify preptin level and relationship with bone disease in chronic kidney disease patients.
Detailed description
Preptin is a 34-aminoacid peptide derived from the E-peptide of pro-insulin-like growth factor 2 (pro-IGF2) that is co-secreted with insulin and upregulates glucose-mediated insulin secretion. High serum preptin levels were described in conditions associated with insulin resistance, such as polycystic ovary syndrome and type 2 diabetes mellitus (T2M). Insulin and also IGF2 are known to be anabolic bone hormones .
Preptin stimulates osteoblastic proliferation and increases mineralization in a concentration-independent manner in osteoblast precursor cell , Despite being associated with insulin resistance, an increased fat mass has beneficial bone effects . While the increased mechanical loading favors bone formation, adipokines and also pancreatic and gut hormones were also proposed to mediate the relationship between fat and bone. The importance of nutritional hormones in maintaining bone mass was, thus, recognized. Insulin has anabolic bone effects, and hyperinsulinemia contributes to increased bone mineral density (BMD). Similar to insulin, insulin-like growth factor 1 (IGF1) and IGF2, preptin was recently proposed to have anabolic bone activity .
End-stage renal disease (ESRD) patients present with specific bone and mineral metabolism disturbances. Chronic kidney disease-associated mineral and bone disorder accounts for increased morbidity and mortality in those patients. Biochemical markers known thus far do not effectively predict the complex bone changes that are observed in ESRD patients .
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- study setting : dialysis unit and outpatient clinic of nephrology study subjects: the study will include 96 participants dividing into three groups of patients control group, chronic kidney disease patients .
Key inclusion criteria (1 listed)
- both sex groups of patients with age between 18-50 years . pre end stage renal disease and end stage renal disease patients .
Key exclusion criteria (1 listed)
- type 2 diabetic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum preptinserum preptin level in chronic kidney disease | Diagnostic test | – |
Primary outcome
Serum Preptin level and its relationship with bone mineral disease in chronic kidney disease patients
Time frame: baseline
To identify preptin level and relationship with bone disease in chronic kidney disease patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Results publication: PubMed 33921361Kaluzna M, Pawlaczyk K, Schwermer K, Hoppe K, Yusuf Ibrahim A, Czlapka-Matyasik M, Wrotkowska E, Ziemnicka K, Oko A, Ruchala M. Is Preptin a New Bone Metabolism Parameter in Hemodialysis Patients? Life (Basel). 2021 Apr 12;11(4):341. doi: 10.3390/life11040341.
- Results publication: PubMed 24593700Livingstone C, Borai A. Insulin-like growth factor-II: its role in metabolic and endocrine disease. Clin Endocrinol (Oxf). 2014 Jun;80(6):773-81. doi: 10.1111/cen.12446. Epub 2014 Mar 24.
- Results publication: PubMed 12215457Zhang M, Xuan S, Bouxsein ML, von Stechow D, Akeno N, Faugere MC, Malluche H, Zhao G, Rosen CJ, Efstratiadis A, Clemens TL. Osteoblast-specific knockout of the insulin-like growth factor (IGF) receptor gene reveals an essential role of IGF signaling in bone matrix mineralization. J Biol Chem. 2002 Nov 15;277(46):44005-12. doi: 10.1074/jbc.M208265200. Epub 2002 Sep 4.
- Results publication: PubMed 24847313Naot D, Cornish J. Cytokines and Hormones That Contribute to the Positive Association between Fat and Bone. Front Endocrinol (Lausanne). 2014 May 9;5:70. doi: 10.3389/fendo.2014.00070. eCollection 2014.
- Results publication: PubMed 20599663Reid IR. Fat and bone. Arch Biochem Biophys. 2010 Nov 1;503(1):20-7. doi: 10.1016/j.abb.2010.06.027. Epub 2010 Jul 3.
- Results publication: PubMed 30729647Xiao C, Li W, Lu T, Wang J, Han J. Preptin promotes proliferation and osteogenesis of MC3T3-E1 cells by upregulating beta-catenin expression. IUBMB Life. 2019 Jul;71(7):854-862. doi: 10.1002/iub.2016. Epub 2019 Feb 6.
- Results publication: PubMed 37755271Ungureanu MC, Bilha SC, Hogas M, Velicescu C, Leustean L, Teodoriu LC, Preda C. Preptin: A New Bone Metabolic Parameter? Metabolites. 2023 Sep 4;13(9):991. doi: 10.3390/metabo13090991.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Preptin, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seham Mohammed Ali, specialist (+2001117279298, aseham146@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Preptin level and its relationship with bone mineral disease in chronic kidney disease patients (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06594042, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.