Relation Between Serum Uric Acid and Metabolic Syndrome in Type 2 DM

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ClinicalTrials.gov Identifier: NCT04575389

Recruitment Status : Not yet recruiting

First Posted : October 5, 2020

Last Update Posted : October 5, 2020

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Sponsor:

Information provided by (Responsible Party):

Esraa Tarek Mahmoud Ahmed, Assiut University

Study Description

Brief Summary:

This study will be undertaken to evaluate the association of serum uric acid (SUA) level with metabolic risk factors in patients with type 2 diabetes and their relation to eGFR status

Condition or disease	Intervention/treatment
Metabolic Syndrome	Diagnostic Test: Serum uric acid levels ,HBA1C , fasting plasma glucose ,lipid profile , creatinine level

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Detailed Description:

Metabolic syndrome (syndrome X, insulin resistance) is a multifactorial disease with multiple risk factors that arises from insulin resistance accompanying abnormal adipose deposition and function . It comprises a combination of risk factors for coronary heart disease, as well as for diabetes type 2 , fatty liver, and several cancers.

Sign and symptoms are ; Hypertension... Hyperglycemia.. Hypertriglyceridemia... Reduced high-density lipoprotein cholesterol (HDL-C).. Abdominal obesity... Chest pain or shortness of breath: Suggesting the rise of cardiovascular and other complications.. The prevalence of the metabolic syndrome is often more in the urban population of some developing countries than in its Western counterparts . The syndrome feeds into the spread of the diseases like type 2 diabetes, coronary diseases, stroke, and other disabilities. The present trend is not sustainable unless a magic cure is found (unlikely) or concerted global/governmental/societal efforts are made to change the lifestyle that is promoting it.

There has been a renewed interest in the association of uric acid with diabetes and its complications. Uric acid is a product of purine metabolism. Increased serum uric acid (SUA) level has been shown to be associated with hypertension(1) cardiovascular disease (CVD)(2) and chronic kidney disease(3) . Elevated SUA level was also associated with metabolic syndrome in both normal subjects as well as in patients with type 2 diabetes. And with type 2 diabetes mellitus(4) Higher SUA level independently predicted the incidence of type 2 diabetes in subjects who had abnormal fasting glucose levels (5) . It has been shown that SUA levels are higher in patients with prediabetic conditions and in patients with type 2 diabetes compared with the level in normal controls (6) . SUA level has been shown to be positively associated with all cause mortality risk, but cardiovascular mortality was associated with SUA level only among those with hyperglycemia (prediabetes and type 2 diabetes)(8) . Hyperuricemia has been found to be associated with risk factors of diabetes such as obesity and insulin resistance(9) . Uric acid has also been reported to be involved in the endothelial dysfunction by impairing nitric oxide production and causing inflammation(10) , These effects of uric acid likely account for its impact on CVD incidence(11) . In acute ischaemic stroke, the survivors with both lower (<4.7 mg/dL) and higher (>6.7 mg/dL) baseline SUA levels had poor outcomes after a 12 month follow up when compared with those who had SUA levels in the range of 4.7-6.7 mg/dL. This is suggestive of the protective nature of uric acid when it is within the optimal range.

SUA level was positively associated with increased incidence of cardiovascular diseases (CVD) in patients with abnormal eGFR (<90 mL/min/1.73 m2) . HbA1c was found to be inversely associated with hyperuricemia in patients with normal eGFR level (≥90 mL/min/1.73 m2). Incidence of metabolic syndrome did not show any relationship with SUA level. However, the incidence of hypertension, a component of metabolic syndrome, was significantly higher among patients with hyperuricemia. Waist circumference and serum triglycerides were higher, whereas serum high-density lipoprotein level was lower in patients with higher SUA level. (12) Serum urea and creatinine were elevated in hyperuricemic patients, suggesting impaired kidney function. Hyperuricemia is known to be associated with the decrease in kidney function (13) and because chronic kidney disease itself elevates SUA level,(14) it is difficult to interpret the causes of the elevated serum urea and creatinine in hyperuricemia. However, eGFR values were only slightly lower in hyperuricemic patients. Correlation analysis showed that both serum urea and creatinine levels were positively associated with SUA level.. This association was found to be significant in patients with normal eGFR levels as well. However, eGFR appears to be negatively associated with SUA level in patients with abnormal eGFR level. Decreased urine output leads to decreased excretion of uric acid, resulting in the elevated SUA level. Therefore, reduction in eGFR may increase SUA levels in these patients.

The importance of uric acid has been increasingly appreciated because of its association with the development of diabetes mellitus and related diseases. SUA level and susceptibility to hyperuricemic conditions depend on the factors such as gender, age and ethnicity. (15) With the increasing incidence of diabetes studying the impact of hyperuricemia in patients with diabetes is necessary.

Study Design

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Study Type :	Observational
Estimated Enrollment :	100 participants
Observational Model:	Case-Control
Time Perspective:	Retrospective
Official Title:	the Association Between Serum Uric Acid Levels and the Risk of Metabolic Syndrome in Type 2 Diabetes Mellitus
Estimated Study Start Date :	October 1, 2020
Estimated Primary Completion Date :	October 2021
Estimated Study Completion Date :	November 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

MedlinePlus related topics: Metabolic Syndrome

Drug Information available for: Uric Acid

U.S. FDA Resources

Groups and Cohorts

Intervention Details:

Diagnostic Test: Serum uric acid levels ,HBA1C , fasting plasma glucose ,lipid profile , creatinine level
diagnostic tests

Outcome Measures

Primary Outcome Measures :

the association of serum uric acid (SUA) level with metabolic risk factors in patients with type 2 diabetes [ Time Frame: baseline ]
the incidence of hypertension, a component of metabolic syndrome, is significantly higher among patients with hyperuricemia. Waist circumference and serum triglycerides are higher, whereas serum high-density lipoprotein level is lower in patients with higher SUA level.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Probability Sample

Study Population

patient will be collected randomly from outpatient clinics of diabetic center of assiut univeristy

Criteria

Inclusion Criteria:

type 2 diabetic patient

Exclusion Criteria:

patients with type 1 diabetes
gestational diabetes
patients with drug affecting uric acid levels
secondary diabetes

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04575389

Contacts

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Contact: esraa tarek, master	01004590619	esraatarek062@gmail.com
Contact: salah abdelazeem, professor	01064559917	argoons@yahoo.com

Sponsors and Collaborators

Assiut University

More Information

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Wang XR, Robinson KM, Carter-Harris L. Prevalence of chronic illnesses and characteristics of chronically ill informal caregivers of persons with dementia. Age Ageing. 2014 Jan;43(1):137-41. doi: 10.1093/ageing/aft142. Epub 2013 Sep 26.

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Woods DJ. Conceptualizing depression and its treatment: comparison of psychoanalytic and behavioral approaches. Psychol Rep. 1975 Dec;37(3 PT 2):1271-8. Review.

Dupuy B, Mounier J, Blanquet P. [Some comments on the biological properties of calcitonin: an eventual new therapeutic utilization (author's transl)]. Ann Endocrinol (Paris). 1977 Jul-Aug;38(4):323-6. French.

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Responsible Party:	Esraa Tarek Mahmoud Ahmed, doctor, Assiut University
ClinicalTrials.gov Identifier:	NCT04575389
Other Study ID Numbers:	metabolic risk factor
First Posted:	October 5, 2020 Key Record Dates
Last Update Posted:	October 5, 2020
Last Verified:	September 2020

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Metabolic Syndrome Syndrome Disease Pathologic Processes Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders	Metabolic Diseases Uric Acid Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs

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