Diabetes Mellitus, Type 1NCT05738577
Apelin as a Marker of Early Complications in Type 1 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 1, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 Feb 2023to 1 Dec 2025
- 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 20 to 30 years
- All sexes
- Adult
Study population: 60 patients with Type 1 Diabetes Mellitus and 30 healthy individuals of the same age group serve as a control group.
Who may be able to join
- type 1 diabetic patients (treated with insulin ). age between 20 to 30 years , including males and females.
- And accepting participation in the study.
Who cannot join
- patients with acute illness.and pregnancy.
Trial locations and contacts
No sites are listed yet.
About this study
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.
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 .
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Apelin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients with type 1 diabetes aged 20-30 years | |
| 2 | healthy people serve as controls of the same age group |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control according to apelin level
Measured: baseline
Secondary outcomes (1)
Detection of the relation of apelin and lipid profile in diabetic 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 posted22 Feb 2023
- Study start25 Feb 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Other
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Mostafa Mohamed Sholkamy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738577
- Sponsor's protocol ID
- assiut123
- Status last verified
- Jan 2023
- First submitted
- 12 Jan 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 34675737Sabry 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apelin as a Marker of Early Complications in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05738577
- Acronym / sponsor ID
- assiut123
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Apelin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Feb 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 22 Feb 2023 (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.
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.
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
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients with type 1 diabetes aged 20-30 years |
| 2 | – | –healthy people serve as controls of the same age group |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Age groups
- Adult
- Study population
- 60 patients with Type 1 Diabetes Mellitus and 30 healthy individuals of the same age group serve as a control group.
Key inclusion criteria (2 listed)
- type 1 diabetic patients (treated with insulin ). age between 20 to 30 years , including males and females.
- And accepting participation in the study.
Key exclusion criteria (1 listed)
- patients with acute illness.and pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
glycemic control according to apelin level
Time frame: baseline
1 secondary outcome
Detection of the relation of apelin and lipid profile in diabetic patients
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Background: PubMed 34675737Al-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.
- Background: PubMed 29731925Sabry 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.
- https://dx.doi.org/10.21608/ejhm.2022.246905Link provided by the sponsor.
- https://doi.org/10.1590/2359-3997000000271Link provided by the sponsor.
- https://doi.org/10.4103%2Fjrms.JRMS\_675\_20Link provided by the sponsor.
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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 Diabetes Mellitus, Type 1, 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 2 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 22 Feb 2023. 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 Reem M Mohamed (+201286900342, remamostafa7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
glycemic control according to apelin level (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 NCT05738577, which also lists 2 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 22 Feb 2023.