ClinicalTrials.gg
Status unknownNCT05738577Updated Feb 22, 2023

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

An observational study in Diabetes Mellitus, Type 1, sponsored by Assiut University. Status unknown. Open to participants aged 20 Years to 30 Years. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jan 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
90
Ages
20 Years to 30 Years
Sex
All
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Study 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.
Read the 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 .

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Conditions studied

  • Diabetes Mellitus, Type 1

Keywords

  • Apelin
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In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's planned enrollment of 90 is below the median of 121 across 769 observational studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 30 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

60 patients with Type 1 Diabetes Mellitus and 30 healthy individuals of the same age group serve as a control group.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • patients with acute illness.and pregnancy.
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Study design

Observational model
Case-control
Time perspective
Other
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • 1

    patients with type 1 diabetes aged 20-30 years

  • 2

    healthy people serve as controls of the same age group

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What researchers measure

Primary outcomes

  1. glycemic control according to apelin level

    Time frame: baseline

Secondary outcomes

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

    Time frame: baseline

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Al-Selwi Y, Shaw JA, Kattner N. Understanding the Pancreatic Islet Microenvironment in Cystic Fibrosis and the Extrinsic Pathways Leading to Cystic Fibrosis Related Diabetes. Clin Med Insights Endocrinol Diabetes. 2021 Oct 12;14:11795514211048813. doi: 10.1177/11795514211048813. eCollection 2021. PubMed 34675737 ↗
  • Sabry RN, El Wakeel MA, El-Kassas GM, Amer AF, El Batal WH, El-Zayat SR, Abou-El-Asrar M. Serum Apelin: A New Marker of Early Atherosclerosis in Children with Type 1 Diabetes Mellitus. Open Access Maced J Med Sci. 2018 Apr 4;6(4):613-617. doi: 10.3889/oamjms.2018.144. eCollection 2018 Apr 15. PubMed 29731925 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2023; primary completion for Dec 2024, 21 months later.

Of 239 non-industry observational studies under Diabetes Mellitus, Type 1, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 78. This study's planned 21 months is below that.

Counting every sponsor, half of 288 studies reached it within 27 months; a quarter within 12 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 12, 2023
First posted
Feb 22, 2023
StartEst.
Feb 25, 2023
Primary completionEst.
Dec 1, 2024
CompletionEst.
Dec 1, 2025
Last update
Feb 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05738577
Lead sponsor
Assiut University
Responsible party
Reem Mostafa Mohamed Sholkamy (resident doctor, Assiut University) — Principal investigator
First posted
Feb 22, 2023
Start date
Feb 25, 2023 (estimated)
Primary completion
Dec 1, 2024 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Feb 22, 2023

Study contacts

Reem M Mohamed
Contact
remamostafa7@gmail.com
+201286900342
Madeeha Y Bakhit, prof
Contact
m.younis@aun.edu.eg
+201009344150

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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