- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298515
Nesfatin-1 Level in Patients With Type 2 Diabetes, Insulin Resistance and Obesity
March 5, 2020 updated by: Gülin Öztürk Özkan, Istanbul Medeniyet University
Determination of the Relationship Between Nesfatin-1 Levels and Energy Intake Levels of Patients With Type 2 Diabetes, Insulin Resistance and Obesity
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gülin Öztürk Özkan, Assis Prof
- Phone Number: 02162803333
- Email: glnzturk@gmail.com
Study Locations
-
-
-
İstanbul, Turkey
- Recruiting
- Haydarpasa Numune Education and Research Hospital
-
Contact:
- Gülin Öztürk Özkan, Assis Prof
- Phone Number: 02162803333
- Email: glnzturk@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 79 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Type 2 Diabetes group
In case of fasting, blood will be taken from patients for the measurement of nesfatin-1.
|
Blood will be taken from the patients on an empty stomach for measuring nesfatin-1 level
|
OTHER: Insulin resistance group
In case of fasting, blood will be taken from patients for the measurement of nesfatin-1.
|
Blood will be taken from the patients on an empty stomach for measuring nesfatin-1 level
|
OTHER: Obesity group
In case of fasting, blood will be taken from patients for the measurement of nesfatin-1.
|
Blood will be taken from the patients on an empty stomach for measuring nesfatin-1 level
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nefratin-1 in type 2 diabetes
Time Frame: 1 day (Blood will be drawn from patients once)
|
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
Time Frame: 1 day (Blood will be drawn from patients once)
|
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
Time Frame: 1 day (Blood will be drawn from patients once)
|
Blood will be drawn from insulin resistance patients after 12 hours of fasting (n=45)
|
1 day (Blood will be drawn from patients once)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Gülin Öztürk Özkan, Assis Prof, Istanbul Medeniyet University
- Study Director: Kadir Kayataş, associate professor, Haydarpasa Numune Education and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
March 2, 2020
Primary Completion (ANTICIPATED)
March 31, 2021
Study Completion (ANTICIPATED)
March 31, 2021
Study Registration Dates
First Submitted
February 10, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (ACTUAL)
March 6, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 6, 2020
Last Update Submitted That Met QC Criteria
March 5, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HNEAH-KAEK 2019/100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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