Evaluation Thyroid Functions in Diabetic PatientAssuitUNCT03154398
Thyroid Dysfunction in Patients With Type 2 Diabetes With Early Diabetic Nephropathy.
An observational study of Evaluation Thyroid Functions in Diabetic Patient, run by Assiut University at 1 site in Egypt.
Trial summary
Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Evaluation Thyroid Functions in Diabetic Patient
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to 1 Dec 2019
- 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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: type 2 diabetes with early nephropthy
Who may be able to join
- Type 2 diabetes mellitus and with diabetic nephropathy.
Who cannot join
- 1) Insulin dependent diabetes 2) Patients with:
- Gestational diabetes mellitus.
- Steroid induced Diabetes.
- 3) Thyroid disease
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (USA) on diabetes .
So, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . The association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. With insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other .
Read more
Diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. Diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis.
As Hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may increase susceptibility to hypoglycemia thus complicating diabetes management so Severe diabetic complications where noted in patients with sub- clinical hypothyroidism . Sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy.
Read the detailed description
Recognition and treatment of thyroid dysfunction in diabetic patients will benefit glycemic control and improve general well-being Diabetic nephropathy, a major microvascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. It results from interactions between hemodynamic and metabolic factors.
- Keywords
- evaluation of thyroid function in diabetes patients
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 | case control |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of patients progress to advanced diabetic nephropathy
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 posted16 May 2017
- Study start1 May 2017
- Primary completion1 May 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation Thyroid Functions in Diabetic PatientStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maria hamdy, Assiut University
- Investigators
- maria hamdy, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154398
- Sponsor's protocol ID
- Assiut1991
- Acronym
- AssuitU
- Status last verified
- Feb 2021
- First submitted
- 14 May 2017
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: evaluate thyroid dysfunction in patients with diabetes in diabetic nephropathy
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thyroid Dysfunction in Patients With Type 2 Diabetes With Early Diabetic Nephropathy.
- ClinicalTrials.gov ID
- NCT03154398
- Acronym / sponsor ID
- AssuitU / Assiut1991
- Keywords
- evaluation of thyroid function in diabetes patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 16 May 2017 (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.
Diabetes Mellitus is the most common disorder seen. The impact of this disease on the quality of life, and on morbidity and mortality through the complications that affect the small and large vessels resulting in retinopathy, nephropathy, neuropathy, and ischemic heart disease has been emphasized by the findings of the national commission (USA) on diabetes .
So, there was curiosity to understand and learn the association of this disorder with another common endocrine gland function that is thyroid gland . The association between these two disorders has long been recognized although the prevalence of thyroid dysfunction in diabetic population varies widely between studies. With insulin and thyroid hormone being intimately involved in cellular metabolism and thus excess or deficit of these hormones result in functional derangement of the other .
Diabetic patients have higher prevalence of thyroid disorder when compared with the normal population. Diabetic women are more frequently affected than men and hypothyroidism is more common than thyrotoxicosis.
As Hyperthyroidism impairs glycemic control in diabetic subjects, while hypothyroidism may increase susceptibility to hypoglycemia thus complicating diabetes management so Severe diabetic complications where noted in patients with sub- clinical hypothyroidism . Sub-clinical hypothyroidism is an independent risk factor for development of diabetic nephropathy.
Detailed description
Recognition and treatment of thyroid dysfunction in diabetic patients will benefit glycemic control and improve general well-being Diabetic nephropathy, a major microvascular complication of type 2 diabetes mellitus, is an important cause of chronic kidney disease. It results from interactions between hemodynamic and metabolic factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –case control |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- type 2 diabetes with early nephropthy
Key inclusion criteria (1 listed)
- Type 2 diabetes mellitus and with diabetic nephropathy.
Key exclusion criteria (4 listed)
- 1) Insulin dependent diabetes 2) Patients with:
- 3) Thyroid disease
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
the percentage of patients progress to advanced diabetic nephropathy
Time frame: one year
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 15 Feb 2021.
- Individual participant dataSharing planned: No. evaluate thyroid dysfunction in patients with diabetes in diabetic nephropathy
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.
maria hamdy study director
Assiut 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 Evaluation Thyroid Functions in Diabetic Patient, run by Assiut 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 4 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 15 Feb 2021. 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?
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?
the percentage of patients progress to advanced diabetic nephropathy (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 15 Feb 2021.