Apelin as a Marker of Early Complications in Type 1 Diabetes Mellitus

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05738577
Collaborator
(none)
90
33.2

Study Details

Study Description

Brief Summary

Aims of the Research :
  1. assessment of serum apelin levels in patients with T1DM with comparison to non-diabetic controls.

  2. investigate the relation between serum apelin levels and glycemic balance.

  3. clarify the the relation between serum apelin and lipid concentrations.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Type 1 Diabetes Mellitus (T1DM) is an endocrine disorder in which pancreatic β cells stop producing insulin due to autoimmune destruction. This results in hyperglycemia and ketosis ; thus insulin replacement is vital in management . Incidence peaks in puberty and early adulthood . Symptoms include polyuria , polydepsia and weight loss. T1DM can cause micro and macrovascular complications which affect the quality of life .

    .Studies proved that TIDM is associated with metabolic abnormalities and alteration of adipose tissue hormones (adipokines). Adipose tissue yields many adipocytokines that modulate insulin sensitivity and play essential role in the pathogenesis of diabetes . Given these complications, we strive to discover new targets that enable us to control DM. One of these targets is apelin .

    Apelin is an adipocytokine widely distributed throughout the body including skeletal muscle, cardiac muscle, pulmonary tissue, mammary glands, ovaries, brain, kidneys, pancreas and adrenal glands.It was extracted from the bovine stomach by Tatemoto et al., in 1998.

    Apelin plays a role in a range of physiological processes including regulation of fluid hemostasis and blood pressure ,improvement of cardiac contractility ,lipid metabolism and metabolic control. It appears to improve insulin sensitivity, reduces blood glucose and increases glucose utilisation .

    It has been shown that apelin has a crucial role in energy metabolism and pathogenesis of diabetes mellitus and its level is altered in diabetic patients .High serum apelin level was linked to impaired insulin sensitivity . Thus, it was suggested that serum apelin can be used for the prediction of development of diabetes and its progression .

    Serum cholesterol, triglycerides (TG) and LDL are significantly increased in T1DM, but serum HDL is decreased . So, patients with T1DM are at high risk of developing premature atherosclerosis because of hyperlipidemia. A correlation was found between serum apelin and cholesterol, TG and LDL in diabetic patients .

    . Apelin was shown to increase the stability of lipid vacuoles making them more resistant to lipolysis. So apelin can be used as a predictor of premature atherosclerosis in T1DM .

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Apelin as a Marker of Early Complications in Type 1 Diabetes Mellitus
    Anticipated Study Start Date :
    Feb 25, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    1

    patients with type 1 diabetes aged 20-30 years

    2

    healthy people serve as controls of the same age group

    Outcome Measures

    Primary Outcome Measures

    1. glycemic control according to apelin level [baseline]

    Secondary Outcome Measures

    1. Detection of the relation of apelin and lipid profile in diabetic patients [baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 30 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • type 1 diabetic patients (treated with insulin ). age between 20 to 30 years , including males and females.

    And accepting participation in the study.

    Exclusion Criteria:
    • patients with acute illness.and pregnancy.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Reem Mostafa Mohamed Sholkamy, resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05738577
    Other Study ID Numbers:
    • assiut123
    First Posted:
    Feb 22, 2023
    Last Update Posted:
    Feb 22, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Reem Mostafa Mohamed Sholkamy, resident doctor, Assiut University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 22, 2023