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

Primary Purpose

Type 2 Diabetes, Insulin Resistance, Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Nesfatin-1

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes focused on measuring Type 2 diabetes, Insulin resistance, Obesity, Nesfatin-1

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Haydarpaşa Numune Education and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Type 2 Diabetes group

Insulin resistance group

Obesity group

Arm Description

In case of fasting, blood will be taken from patients for the measurement of nesfatin-1.

Outcomes

Primary Outcome Measures

Nefratin-1 in type 2 diabetes

Blood will be drawn from type 2 diabates patients after 12 hours of fasting (n=45)

Nefratin-1 in obesity

Blood will be drawn from obesity patients after 12 hours of fasting (n=45)

Nefratin-1 in insulin resistance

Blood will be drawn from insulin resistance patients after 12 hours of fasting (n=45)

Secondary Outcome Measures

Full Information

NCT ID

NCT04298515

First Posted

February 10, 2020

Last Updated

March 5, 2020

Sponsor

Istanbul Medeniyet University

1. Study Identification

Unique Protocol Identification Number

NCT04298515

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 2, 2020 (Anticipated)

Primary Completion Date

March 31, 2021 (Anticipated)

Study Completion Date

March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Insulin Resistance, Obesity, Nesfatin-1

Keywords

Type 2 diabetes, Insulin resistance, Obesity, Nesfatin-1

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Type 2 Diabetes group

Arm Type

Other

Arm Description

In case of fasting, blood will be taken from patients for the measurement of nesfatin-1.

Arm Title

Insulin resistance group

Arm Type

Other

Arm Description

In case of fasting, blood will be taken from patients for the measurement of nesfatin-1.

Arm Title

Obesity group

Arm Type

Other

Arm Description

In case of fasting, blood will be taken from patients for the measurement of nesfatin-1.

Intervention Type

Diagnostic Test

Intervention Name(s)

Nesfatin-1

Intervention Description

Blood will be taken from the patients on an empty stomach for measuring nesfatin-1 level

Primary Outcome Measure Information:

Title

Nefratin-1 in type 2 diabetes

Description

Blood will be drawn from type 2 diabates patients after 12 hours of fasting (n=45)

Time Frame

1 day (Blood will be drawn from patients once)

Title

Nefratin-1 in obesity

Description

Blood will be drawn from obesity patients after 12 hours of fasting (n=45)

Time Frame

1 day (Blood will be drawn from patients once)

Title

Nefratin-1 in insulin resistance

Description

Blood will be drawn from insulin resistance patients after 12 hours of fasting (n=45)

Time Frame

1 day (Blood will be drawn from patients once)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gülin Öztürk Özkan, Assis Prof

Phone

02162803333

glnzturk@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gülin Öztürk Özkan, Assis Prof

Organizational Affiliation

İstanbul Medeniyet University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Kadir Kayataş, associate professor

Organizational Affiliation

Haydarpaşa Numune Education and Research Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Haydarpaşa Numune Education and Research Hospital

City

İstanbul

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gülin Öztürk Özkan, Assis Prof

Phone

02162803333

glnzturk@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27754932

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.

Results Reference

background

PubMed Identifier

25470645

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.

Results Reference

background

PubMed Identifier

19896982

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.

Results Reference

result

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/?term=10.1530%2FJOE-16-0361

Description

Review

URL

http://www.ncbi.nlm.nih.gov/pubmed/?term=19896982

Description

Original research

URL

http://www.ncbi.nlm.nih.gov/pubmed/?term=10.1016%2Fj.dsx.2014.04.010

Description

Original research

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

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