NCT04298515

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

March 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

March 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

February 10, 2020

Last Update Submit

March 5, 2020

Conditions

Type 2 DiabetesInsulin ResistanceObesityNesfatin-1

Keywords

Type 2 diabetesInsulin resistanceObesityNesfatin-1

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (3)

Type 2 Diabetes group

OTHER

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

Diagnostic Test: Nesfatin-1

Insulin resistance group

OTHER

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

Diagnostic Test: Nesfatin-1

Obesity group

OTHER

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

Diagnostic Test: Nesfatin-1

Interventions

Nesfatin-1DIAGNOSTIC_TEST

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

Insulin resistance groupObesity groupType 2 Diabetes group

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • Insulin resistance
  • Obesity disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydarpaşa Numune Education and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related 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. doi: 10.1530/JOE-16-0361. Epub 2016 Oct 17.

    PMID: 27754932BACKGROUND

  • 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.

    PMID: 25470645BACKGROUND

  • 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.

    PMID: 19896982RESULT

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin ResistanceObesity

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinismOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gülin Öztürk Özkan, Assis Prof

    İstanbul Medeniyet University

    STUDY CHAIR

  • Kadir Kayataş, associate professor

    Haydarpaşa Numune Education and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Gülin Öztürk Özkan, Assis Prof

CONTACT

02162803333glnzturk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 10, 2020

First Posted

March 6, 2020

Study Start

March 2, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

March 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)