Apelin as a Marker of Early Complications in Type 1 Diabetes Mellitus
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| ClinicalTrials.gov Identifier: NCT05738577 |
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Recruitment Status :
Not yet recruiting
First Posted : February 22, 2023
Last Update Posted : February 22, 2023
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Aims of the Research :
- assessment of serum apelin levels in patients with T1DM with comparison to non-diabetic controls.
- investigate the relation between serum apelin levels and glycemic balance.
- clarify the the relation between serum apelin and lipid concentrations.
| Condition or disease |
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| Diabetes Mellitus, Type 1 |
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 Type : | Observational |
| Estimated Enrollment : | 90 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Other |
| Official Title: | Apelin as a Marker of Early Complications in Type 1 Diabetes Mellitus |
| Estimated Study Start Date : | February 25, 2023 |
| Estimated Primary Completion Date : | December 1, 2024 |
| Estimated Study Completion Date : | December 1, 2025 |
| Group/Cohort |
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patients with type 1 diabetes aged 20-30 years
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healthy people serve as controls of the same age group
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- glycemic control according to apelin level [ Time Frame: baseline ]
- Detection of the relation of apelin and lipid profile in diabetic patients [ Time Frame: baseline ]
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| Ages Eligible for Study: | 20 Years to 30 Years (Adult) |
| Sexes Eligible for Study: | All |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05738577
| Contact: Reem M Mohamed | +201286900342 | remamostafa7@gmail.com | |
| Contact: Madeeha Y Bakhit, prof | +201009344150 | m.younis@aun.edu.eg |
Publications:
| Responsible Party: | Reem Mostafa Mohamed Sholkamy, resident doctor, Assiut University |
| ClinicalTrials.gov Identifier: | NCT05738577 |
| Other Study ID Numbers: |
assiut123 |
| First Posted: | February 22, 2023 Key Record Dates |
| Last Update Posted: | February 22, 2023 |
| Last Verified: | January 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Apelin |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |