Clinical trial NCT04298515: Nesfatin-1 Level in Patients With Type 2 Diabetes, Insulin Resistance and Obesity
Official title: Determination of the Relationship Between Nesfatin-1 Levels and Energy Intake Levels of Patients With Type 2 Diabetes, Insulin Resistance and Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Insulin Resistance
Obesity
Nesfatin-1
Keywords: Type 2 diabetes
Insulin resistance
Obesity
Nesfatin-1
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This research was planned to determine the level of nesfatin-1, known as satiety hormone, in type 2 diabetes, insulin diabetes and obesity patients and to determine whether there is a relationship between patients' energy intake levels. Additionally, it was aimed to evaluate the relationship between patients' nesfatin-1 values and serum glucose, insulin, lipid concentrations.

Detailed description: Nesfatin-1 levels of patients with type 2 diabetes, insulin resistance and obesity will be measured. In addition, patients' daily food consumption will be taken and the amount of energy they receive will be calculated daily. The relationship between the level of nesfatin-1 in the blood and the energy received will be examined.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Insulin resistance
* Obesity disease

Exclusion Criteria:

* Pediatric individuals
* All patients who are hospitalized,
* Liver disease
* Cancer patients
* Disease related to the gastrointestinal tract
* Nephrological disease such as chronic kidney failure, acute kidney failure, nephrotic syndrome
* Neurological disease

Primary outcomes:
measure: Nefratin-1 in type 2 diabetes
timeFrame: 1 day (Blood will be drawn from patients once)
measure: Nefratin-1 in obesity
timeFrame: 1 day (Blood will be drawn from patients once)
measure: Nefratin-1 in insulin resistance
timeFrame: 1 day (Blood will be drawn from patients once)
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Haydarpaşa Numune Education and Research Hospital
Study officials:
affiliation: İstanbul Medeniyet University
name: Gülin Öztürk Özkan, Assis Prof
role: STUDY_CHAIR
affiliation: Haydarpaşa Numune Education and Research Hospital
name: Kadir Kayataş, associate professor
role: STUDY_DIRECTOR
References:
citation: Dore R, Levata L, Lehnert H, Schulz C. Nesfatin-1: functions and physiology of a novel regulatory peptide. J Endocrinol. 2017 Jan;232(1):R45-R65. doi: 10.1530/JOE-16-0361. Epub 2016 Oct 17.
citation: Mirzaei K, Hossein-nezhad A, Keshavarz SA, Koohdani F, Eshraghian MR, Saboor-Yaraghi AA, Hosseini S, Chamari M, Zareei M, Djalali M. Association of nesfatin-1 level with body composition, dietary intake and resting metabolic rate in obese and morbid obese subjects. Diabetes Metab Syndr. 2015 Oct-Dec;9(4):292-8. doi: 10.1016/j.dsx.2014.04.010. Epub 2014 May 25.
citation: Li QC, Wang HY, Chen X, Guan HZ, Jiang ZY. Fasting plasma levels of nesfatin-1 in patients with type 1 and type 2 diabetes mellitus and the nutrient-related fluctuation of nesfatin-1 level in normal humans. Regul Pept. 2010 Jan 8;159(1-3):72-7. doi: 10.1016/j.regpep.2009.11.003.