Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
90 participants
OBSERVATIONAL
2022-01-01
2023-06-30
Brief Summary
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Detailed Description
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The conventional medications in diabetes treatment, oral and insulin, are focusing on insulin secretion and insulin sensitisation. Oral antidiabetics include, Biguanides, Sulfonylureas, Thiazolidinediones, DPP4 inhibitors, GLP-1 analogue, and SGLT2 inhibitors.
Irisin, a myokin and adipokine secreted by muscles and subcutaneous fat, is an interesting peptide performing significant functions in human health. Irisin has been linked to human obesity and insulin resistance status.
Irisin is involved in regulating the mitochondrial function of muscle cells, so increases energy consumption of the body, promotes metabolism and reduces body weight so improves insulin sensetivity. In our study we aim to clarify the effect of antidiabetics on serum irisin in patients with typeII DM who developed diabetic nephropathy.
Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Patient Group
The patient group will include 60 patients with type II DM. They will be subdivided into three groups according to albumin-creatinine ratio ,normoalbuminuric group(less than 30mg/g),which will include 20 patients, microalbuminuric group (ACR =30-300 mg/), which will include 20 patients, and macroalbuminuric group (ACR more than 300mg/g),which will include 20 patients.
Laboratory tests
Fasting blood glucose (FBG), postprandial blood glucose, total cholesterol (CHO), triglycerides (TG), high-density lipoprotein cholesterol and low-density lipoprotein cholesterol (LDL-C), urea, creatinine, and uric acid by point colorimetric assay.
Serum irisin.
Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) was calculated by EPI equation.
Control Group
control group will include 30 apparently healthy age-matched and sex-matched individuals.
Anthropometric measurements
Height, weight, waist circumference, and hip circumference were taken as a way of assessing the nutritional status and BMI
Electrocardiogram and Fundus examination
Fundus examination by direct ophthalmoscope
Brachial index
The ankle-brachial index test compares the blood pressure measured at your ankle with the blood pressure measured at your arm
Laboratory tests
Glycosylated haemoglobin. ACR,urinary albumin (mg) and creatinine (g).
Abdominal ultrasound.
It will be performed for patients only.
Interventions
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Laboratory tests
Fasting blood glucose (FBG), postprandial blood glucose, total cholesterol (CHO), triglycerides (TG), high-density lipoprotein cholesterol and low-density lipoprotein cholesterol (LDL-C), urea, creatinine, and uric acid by point colorimetric assay.
Serum irisin.
Anthropometric measurements
Height, weight, waist circumference, and hip circumference were taken as a way of assessing the nutritional status and BMI
Electrocardiogram and Fundus examination
Fundus examination by direct ophthalmoscope
Estimated glomerular filtration rate (eGFR)
Estimated glomerular filtration rate (eGFR) was calculated by EPI equation.
Brachial index
The ankle-brachial index test compares the blood pressure measured at your ankle with the blood pressure measured at your arm
Laboratory tests
Glycosylated haemoglobin. ACR,urinary albumin (mg) and creatinine (g).
Abdominal ultrasound.
It will be performed for patients only.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with type 1 diabetes complicated with diabetic nephropathy
* Type2 diabetes without nephropathy.
* Diabetic nephropathy cases on dialysis due to other causes
* Blood pressure more than 160/100
* Acute coronary syndrome in the past 6 months
* Non alcoholic fatty liver disease, impaired liver function.
* Malignancy.
* Pregnancy
* Acute infection, acute inflammation.
* Severe renal impairment, and urinary tract infection.
40 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Hadeer S. Hassan
principal investigator
Central Contacts
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References
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Xuan X, Lin J, Zhang Y, Zhou L, Xu L, Jia J, Zhao B, Lin Z, Zhu Q, Li L, Wu T, Zhang S, Jiang H, Wang Y. Serum Irisin Levels and Clinical Implication in Elderly Patients With Type 2 Diabetes Mellitus. J Clin Med Res. 2020 Sep;12(9):612-617. doi: 10.14740/jocmr4261. Epub 2020 Aug 15.
Ravaut M, Sadeghi H, Leung KK, Volkovs M, Kornas K, Harish V, Watson T, Lewis GF, Weisman A, Poutanen T, Rosella L. Predicting adverse outcomes due to diabetes complications with machine learning using administrative health data. NPJ Digit Med. 2021 Feb 12;4(1):24. doi: 10.1038/s41746-021-00394-8.
Tan SY, Mei Wong JL, Sim YJ, Wong SS, Mohamed Elhassan SA, Tan SH, Ling Lim GP, Rong Tay NW, Annan NC, Bhattamisra SK, Candasamy M. Type 1 and 2 diabetes mellitus: A review on current treatment approach and gene therapy as potential intervention. Diabetes Metab Syndr. 2019 Jan-Feb;13(1):364-372. doi: 10.1016/j.dsx.2018.10.008. Epub 2018 Oct 10.
Other Identifiers
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AATHSH
Identifier Type: -
Identifier Source: org_study_id