Clinical trial NCT05144672: Irisin And Diabetic Nephropathy
Official title: Irisin Level in Patients With Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irisin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Any patients above 40 years with type 2 diabetes of at least two years duration complicated with diabetic nephropathy.

Brief summary: Diabetes mellitus (DM) is a complex, multifactorial, chronic metabolic and endocrine disorder. It has become a threat to global health. It has two types. It is estimated that the number of people with type II will reach 700 million by 2045.

Detailed description: It is associated with acute and chronic complications, acute complications include hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar state, and hyperglycemic diabetic coma. Chronic complications are further divided into microvascular and macrovascular complications. Chronic microvascular complications are neuropathy, retinopathy, and nephropathy. The later one firstly diagnosed by microalbuminuria. whereas chronic macrovascular complications are coronary artery disease (CAD), peripheral artery disease (PAD), and cerebrovascular disease.

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.

Eligibility criteria: Inclusion Criteria:

Any patients above 40 years with type 2 diabetes of at least two years duration complicated with diabetic nephropathy.

Exclusion Criteria:

* Patients below 40 yrs.
* 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.

Primary outcomes:
measure: The relation between different stages of diabetic nephropathy and irisin level.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.