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NCT04298515 Clinical Trial

Nesfatin-1 Level in Patients With Type 2 Diabetes, Insulin Resistance and Obesity

Obesity Clinical Trial

Official title:
Determination of the Relationship Between Nesfatin-1 Levels and Energy Intake Levels of Patients With Type 2 Diabetes, Insulin Resistance and Obesity

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04298515
Other study ID # HNEAH-KAEK 2019/100
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2, 2020
Est. completion date March 31, 2021

Study information
Verified date February 2020
Source Istanbul Medeniyet University
Contact Gülin Öztürk Özkan, Assis Prof
Phone 02162803333
Email glnzturk@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 180
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 79 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Nesfatin-1
Blood will be taken from the patients on an empty stomach for measuring nesfatin-1 level

Locations
Country Name City State
Turkey Haydarpasa Numune Education and Research Hospital Istanbul

Sponsors (1)
Lead Sponsor Collaborator
Istanbul Medeniyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. Epub 2016 Oct 17. Review. — View 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: 10.10 — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Nefratin-1 in type 2 diabetes Blood will be drawn from type 2 diabates patients after 12 hours of fasting (n=45) 1 day (Blood will be drawn from patients once)
Primary Nefratin-1 in obesity Blood will be drawn from obesity patients after 12 hours of fasting (n=45) 1 day (Blood will be drawn from patients once)
Primary Nefratin-1 in insulin resistance Blood will be drawn from insulin resistance patients after 12 hours of fasting (n=45) 1 day (Blood will be drawn from patients once)
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