Diabete Type 2NCT04218305
Fetuin-A as a Marker in Obesity and Type 2 Diabetes Mellitus
An observational study of Diabete Type 2, run by Minia University.
Trial summary
The aim of this study is to assess the significance of serum fetuin-A as a marker of obesity and type 2 diabetes mellitus. We used multiple statistical approaches to determine that the fetuin-A level is correlated to body mass index (BMI) as well as random blood sugar in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- Serum Level Of Fetuin A
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Mar 2016
- 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 45 to 60 years
- All sexes
- Adult
Study population: obese and type 2 diabetic patients aged 45-60 years old. and control healthy adult persons
Who may be able to join
- • The study included obese and type 2 diabetic patients aged 45-60 years old. and control healthy adult persons
Who cannot join
- • Cardiac disease and Hypertensive disease
- Respiratory disease
- Renal disease
- GIT and Liver disease
- Rheumatologic disease
- Blood disease
- Endocrine disease except for type 2 diabetes mellitus
- All with a specific therapeutic drug history.
About this study
Official title: Study of Using Serum Fetuin-A as a Marker in Obesity and Type 2 Diabetes Mellitus
The aim of this study is to assess the significance of serum fetuin-A as a marker of obesity and type 2 diabetes mellitus. We used multiple statistical approaches to determine that the fetuin-A level is correlated to body mass index (BMI) as well as random blood sugar in type 2 diabetic patients. Also, we found that there is a Positive correlation between the serum fetuin-A levels and the level of glycosylated hemoglobin (HbA1c) in diabetic patients.
Read the detailed description
The study was a case-control study. We started the study to be performed on eighty subjects divided into four groups:
The first group: include twenty subjects with type 2 diabetes mellitus The second group: include twenty obese subjects whose body mass index is 30 or over The third group: include twenty obese subjects with type 2 diabetes mellitus The fourth group includes twenty apparently healthy subjects as control.
In this study, we concluded that:
- Serum fetuin-A can be used as a biomarker and independent risk factor and marker for diagnosis of DM and DM has a detrimental effect on serum fetuin-A fetuin-A could be of relevance for the development of insulin resistance
- Higher fetuin-A concentrations were associated with type 2 diabetes and insulin resistance
- Increased serum fetuin-A levels constitute an independent marker of lipid profile.
- fetuin-A may play a role in the pathogenesis of T2DM.
- The inhibition of insulin receptor by fetuin-A may lead to increased lipolysis and efflux of free fatty acids from adipose tissue. This could explain associated dyslipidemia observed in type 2 diabetic patients in the present study.
Finally, our finding that high plasma fetuin-A levels predict the incidence of type 2 diabetes independently of other established risk factors supports the hypothesis that fetuin-A may play a role in the development of type 2 diabetes.
- Conditions
- Diabete Type 2
- Being tested
- Serum Level Of Fetuin A
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Level Of Fetuin ADiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| The first group | Include One hundred patients with type 2 diabetes mellitus with average body mass index. Receives: Diagnostic Test: Serum Level Of Fetuin A | |
| The second group | Include One hundred patients whose body mass index is 30 or over without diabetes. Receives: Diagnostic Test: Serum Level Of Fetuin A | |
| The third group | Include One hundred type 2 diabetic obese patients whose body mass index is 30 or over. Receives: Diagnostic Test: Serum Level Of Fetuin A | |
| The fourth group | Include One hundred apparently healthy adult person as a control. Receives: Diagnostic Test: Serum Level Of Fetuin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Study of human serum fetuin-A and whether it is involved in insulin resistance
2- To assess the significance of serum fetuin-A as a marker in obesity and type 2 diabetes mellitus
Measured: Baesline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Jan 2016
- Primary completion1 Feb 2016
- Study completion1 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Minia 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
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Mohammad Ahmad, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218305
- Sponsor's protocol ID
- fetuin-A as a marker
- Status last verified
- Jan 2020
- First submitted
- 2 Jan 2020
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Using Serum Fetuin-A as a Marker in Obesity and Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04218305
- Acronym / sponsor ID
- fetuin-A as a marker
- Conditions
- Diabete Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Feb 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 6 Jan 2020 (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.
The aim of this study is to assess the significance of serum fetuin-A as a marker of obesity and type 2 diabetes mellitus. We used multiple statistical approaches to determine that the fetuin-A level is correlated to body mass index (BMI) as well as random blood sugar in type 2 diabetic patients. Also, we found that there is a Positive correlation between the serum fetuin-A levels and the level of glycosylated hemoglobin (HbA1c) in diabetic patients.
Detailed description
The study was a case-control study. We started the study to be performed on eighty subjects divided into four groups:
The first group: include twenty subjects with type 2 diabetes mellitus The second group: include twenty obese subjects whose body mass index is 30 or over The third group: include twenty obese subjects with type 2 diabetes mellitus The fourth group includes twenty apparently healthy subjects as control.
In this study, we concluded that:
- Serum fetuin-A can be used as a biomarker and independent risk factor and marker for diagnosis of DM and DM has a detrimental effect on serum fetuin-A fetuin-A could be of relevance for the development of insulin resistance
- Higher fetuin-A concentrations were associated with type 2 diabetes and insulin resistance
- Increased serum fetuin-A levels constitute an independent marker of lipid profile.
- fetuin-A may play a role in the pathogenesis of T2DM.
- The inhibition of insulin receptor by fetuin-A may lead to increased lipolysis and efflux of free fatty acids from adipose tissue. This could explain associated dyslipidemia observed in type 2 diabetic patients in the present study.
Finally, our finding that high plasma fetuin-A levels predict the incidence of type 2 diabetes independently of other established risk factors supports the hypothesis that fetuin-A may play a role in the development of type 2 diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| The first group | – | Diagnostic Test: Serum Level Of Fetuin AInclude One hundred patients with type 2 diabetes mellitus with average body mass index. |
| The second group | – | Diagnostic Test: Serum Level Of Fetuin AInclude One hundred patients whose body mass index is 30 or over without diabetes. |
| The third group | – | Diagnostic Test: Serum Level Of Fetuin AInclude One hundred type 2 diabetic obese patients whose body mass index is 30 or over. |
| The fourth group | – | Diagnostic Test: Serum Level Of Fetuin AInclude One hundred apparently healthy adult person as a control. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- obese and type 2 diabetic patients aged 45-60 years old. and control healthy adult persons
Key inclusion criteria (1 listed)
- • The study included obese and type 2 diabetic patients aged 45-60 years old. and control healthy adult persons
Key exclusion criteria (8 listed)
- • Cardiac disease and Hypertensive disease
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 Level Of Fetuin A | Diagnostic test | The first group, The fourth group, The second group, The third group |
Primary outcome
1- Study of human serum fetuin-A and whether it is involved in insulin resistance
Time frame: Baesline
2- To assess the significance of serum fetuin-A as a marker in obesity and type 2 diabetes mellitus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2, run by Minia 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 8 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: finished, as of the sponsor's last update on 6 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1- Study of human serum fetuin-A and whether it is involved in insulin resistance (time frame: Baesline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2020.