Assess Level of High Sensitive CRP in Diabetics and PrediabeticsNCT03673904
High Sensitive CRP in Prediabetics and Diabetes
An observational study of Assess Level of High Sensitive CRP in Diabetics and Prediabetics, run by Fayoum University.
Trial summary
The aim of this study was to study the level of high-sensitivity CRP in sera of pre-diabetic and newly diagnosed patients with type 2 diabetes mellitus and its correlation with HOMA IR and HbA1c Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Assess Level of High Sensitive CRP in Diabetics and Prediabetics
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 8 Mar 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study individuals were recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital
Who may be able to join
- Pre-diabetic patients:
- A fasting blood glucose level (100 to 125 mg/dL). or
- A 2-hour blood glucose level (140 to 199 mg/dL) .or
- Hb A1C 5.7% to 6.4%.
- Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis)
- A fasting blood glucose level >126 mg/dl
- A 2-hour blood glucose level > 200 mg/dl
- Hb A1C > 6.5%
Who cannot join
- Pregnant or lactating females.
- Patients who have recent infection.
- Patients with acute inflammatory diseases as autoimmune diseases.
- Patients with malignancy or on chemotherapy.
- Patients with acute or chronic liver or renal diseases
About this study
Official title: High Sensitive CRP Level in Prediabetics and Newly Diagnosed Type 2 Diabetic Patients
The aim of this study was to study the level of high-sensitivity CRP in sera of pre-diabetic and newly diagnosed patients with type 2 diabetes mellitus and its correlation with HOMA IR and HbA1c
Read the detailed description
This study will include (180) subjects, 60 pre-diabetic patients, 60 patients with newly diagnosed type 2 diabetes ( within one month of diagnosis) and 60 normal healthy non diabetic individuals as a control group. The study individuals will be recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital
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 |
|---|---|---|
| Prediabetics | Ages ranging from 18 to 60 years old,males and females were included . A fasting blood glucose level (100 to 125 mg/dL). or A 2-hour blood glucose level (140 to 199 mg/dL) .or Hb A1C 5.7% to 6.4%. | |
| Newly diagnosed type 2 diabetes | Ages ranging from 18 to 60 years old,males and females were included Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis) A fasting blood glucose level >126 mg/dl A 2-hour blood glucose level > 200 mg/d Hb A1C > 6.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
statistical significant elevation of high sensitive CRP in diabetics and prediabetes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Jan 2017
- Primary completion10 Feb 2018
- Study completion8 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess Level of High Sensitive CRP in Diabetics and PrediabeticsStudies of the same condition, open and under way.
- More trials run by Fayoum 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 only
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelkawi Hammad, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673904
- Sponsor's protocol ID
- D84
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: still to be decided later
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Sensitive CRP Level in Prediabetics and Newly Diagnosed Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT03673904
- Acronym / sponsor ID
- D84
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 10 Feb 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 17 Sep 2018 (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 was to study the level of high-sensitivity CRP in sera of pre-diabetic and newly diagnosed patients with type 2 diabetes mellitus and its correlation with HOMA IR and HbA1c
Detailed description
This study will include (180) subjects, 60 pre-diabetic patients, 60 patients with newly diagnosed type 2 diabetes ( within one month of diagnosis) and 60 normal healthy non diabetic individuals as a control group. The study individuals will be recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prediabetics | – | –Ages ranging from 18 to 60 years old,males and females were included . A fasting blood glucose level (100 to 125 mg/dL). or A 2-hour blood glucose level (140 to 199 mg/dL) .or Hb A1C 5.7% to 6.4%. |
| Newly diagnosed type 2 diabetes | – | –Ages ranging from 18 to 60 years old,males and females were included Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis) A fasting blood glucose level >126 mg/dl A 2-hour blood glucose level > 200 mg/d Hb A1C > 6.5% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study individuals were recruited from the Diabetes and Internal Medicine Clinics of Fayoum University Hospital
Key inclusion criteria (8 listed)
- Pre-diabetic patients:
- Newly diagnosed type 2 diabetes: (maximum within one month from diagnosis)
Key exclusion criteria (5 listed)
- Pregnant or lactating females.
- Patients who have recent infection.
- Patients with acute inflammatory diseases as autoimmune diseases.
- Patients with malignancy or on chemotherapy.
- Patients with acute or chronic liver or renal diseases
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
statistical significant elevation of high sensitive CRP in diabetics and prediabetes
Time frame: 2 years
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 17 Sep 2018.
- Individual participant dataSharing planned: Undecided. still to be decided later
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 Assess Level of High Sensitive CRP in Diabetics and Prediabetics, run by Fayoum 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 8 inclusion and 5 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 17 Sep 2018. 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?
statistical significant elevation of high sensitive CRP in diabetics and prediabetes (time frame: 2 years). 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 17 Sep 2018.