Visceral FatNCT06112197
Study of Visceral Fat in type2diabetic Patients and Its Relation to Microvascular Complications
An observational study of Visceral Fat and Insulin Resistance, run by Sohag University at 1 site in Egypt.
Trial summary
Study the correlation between METS IR and visceral fat in type 2 diabetes and its relation to microvascular complication Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Fat, Insulin Resistance
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2024to 5 Jun 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of T2DM, either newly diagnosed or previously diagnosed and on treatment with antidiabetic oral hypoglycemic agents or insulin and attending diabetes OPD or admitted to the Medicine Department, were taken as cases. Age- and gender-matched nondiabetic people admitted to the Medicine Department were taken as control subjects. Both these groups will be interviewed, examined, investigated, and included in the study.
Who may be able to join
- Age > 18 years Both male and female subjects Subjects capable of giving consent and voluntarily willing to participate in the study
Who cannot join
- Chronic kidney disease patients Any nondiabetic nephropathy patients Patients affected by hypertension Patients affected by ocular disorders Neuropathies of other etiologies like chronic liver disease patients, alcoholics, or drug addicts Critically ill patients of type 2 diabetes mellitus Patients who have not given consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Visceral Fat in Type 2diabetic Patients and Its Relation to Microvascular Complications
Study the correlation between METS IR and visceral fat in type 2 diabetes and its relation to microvascular complication
Read the detailed description
The Metabolic Score for Insulin Resistance (METS-IR) is a metabolic index developed with the aim to quantify peripheral insulin sensitivity in humans; it was first described under the name METS-IR by Bello-Chavolla et al in 2018. It was developed by the Metabolic Research Disease Unit at the Institute National de Ciencias Médicas Salvador Zubirán and validated against the euglycemic hyperinsulinemic clamp and the frequently-sampled intravenous glucose tolerance test in Mexican population.It is a non-insulin-based alternative to insulin-based methods to quantify peripheral insulin sensitivity and an alternative to the Homeostatic Model Assessment (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI).
Very limited research correlate between visceral obesity and microvascular complications in type 2 diabetic patients and how can the metabolic score for insulin resistance predict visceral obesity and microvascular complications in type2 diabetic patients. In this study the investigators will search for these correlations.
- Conditions
- Visceral Fat, Insulin Resistance
- Medical subject headings
- Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between METS IR and visceral fat in type 2 diabetes
Study the cor relation between METS IR and visceral fat in type 2 diabetes and its relation to microvascular complication
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start5 Jan 2024 (estimated)
- Primary completion5 Jan 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral FatStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Soliman, Sohag University
- Investigators
- mahmoud soliman, Study director, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112197
- Sponsor's protocol ID
- Soh-Med-23-10-13MD
- Status last verified
- Oct 2023
- First submitted
- 26 Oct 2023
- Last updated
- 2 Nov 2023
- 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 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Visceral Fat in Type 2diabetic Patients and Its Relation to Microvascular Complications
- ClinicalTrials.gov ID
- NCT06112197
- Acronym / sponsor ID
- Soh-Med-23-10-13MD
- Conditions
- Visceral Fat, Insulin Resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (estimated)
- Primary completion
- 5 Jan 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 1 Nov 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.
Study the correlation between METS IR and visceral fat in type 2 diabetes and its relation to microvascular complication
Detailed description
The Metabolic Score for Insulin Resistance (METS-IR) is a metabolic index developed with the aim to quantify peripheral insulin sensitivity in humans; it was first described under the name METS-IR by Bello-Chavolla et al in 2018. It was developed by the Metabolic Research Disease Unit at the Institute National de Ciencias Médicas Salvador Zubirán and validated against the euglycemic hyperinsulinemic clamp and the frequently-sampled intravenous glucose tolerance test in Mexican population.It is a non-insulin-based alternative to insulin-based methods to quantify peripheral insulin sensitivity and an alternative to the Homeostatic Model Assessment (HOMA-IR) and the quantitative insulin sensitivity check index (QUICKI).
Very limited research correlate between visceral obesity and microvascular complications in type 2 diabetic patients and how can the metabolic score for insulin resistance predict visceral obesity and microvascular complications in type2 diabetic patients. In this study the investigators will search for these correlations.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of T2DM, either newly diagnosed or previously diagnosed and on treatment with antidiabetic oral hypoglycemic agents or insulin and attending diabetes OPD or admitted to the Medicine Department, were taken as cases. Age- and gender-matched nondiabetic people admitted to the Medicine Department were taken as control subjects. Both these groups will be interviewed, examined, investigated, and included in the study.
Key inclusion criteria (1 listed)
- Age > 18 years Both male and female subjects Subjects capable of giving consent and voluntarily willing to participate in the study
Key exclusion criteria (1 listed)
- Chronic kidney disease patients Any nondiabetic nephropathy patients Patients affected by hypertension Patients affected by ocular disorders Neuropathies of other etiologies like chronic liver disease patients, alcoholics, or drug addicts Critically ill patients of type 2 diabetes mellitus Patients who have not given consent
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
correlation between METS IR and visceral fat in type 2 diabetes
Time frame: one year
Study the cor relation between METS IR and visceral fat in type 2 diabetes and its relation to microvascular complication
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2023.
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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.
mahmoud soliman study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Fat and Insulin Resistance, run by Sohag University at 1 site in Egypt.
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 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 2 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
correlation between METS IR and visceral fat in type 2 diabetes (time frame: one year). 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 2 Nov 2023.