Type 2 DiabetesNCT04298515
Nesfatin-1 Level in Patients With Type 2 Diabetes, Insulin Resistance and Obesity
A study testing Nesfatin-1 in people with Type 2 Diabetes and Insulin Resistance, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 19 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Insulin Resistance, Obesity
- What is being tested?
- Nesfatin-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes
- Insulin resistance
- Obesity disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Haydarpaşa Numune Education and Research Hospital
Istanbul
Gülin Öztürk Özkan, Assis Prof, 02162803333, glnzturk@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes, Insulin Resistance, Obesity, Nesfatin-1
- Being tested
- Nesfatin-1
- Keywords
- Type 2 diabetes, Insulin resistance, Obesity, Nesfatin-1
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nesfatin-1Diagnostic test
Blood will be taken from the patients on an empty stomach for measuring nesfatin-1 level
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes group | Other | In case of fasting, blood will be taken from patients for the measurement of nesfatin-1. Receives: Diagnostic Test: Nesfatin-1 |
| Insulin resistance group | Other | In case of fasting, blood will be taken from patients for the measurement of nesfatin-1. Receives: Diagnostic Test: Nesfatin-1 |
| Obesity group | Other | In case of fasting, blood will be taken from patients for the measurement of nesfatin-1. Receives: Diagnostic Test: Nesfatin-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nefratin-1 in type 2 diabetes
Blood will be drawn from type 2 diabates patients after 12 hours of fasting (n=45)
Measured: 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)
Measured: 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)
Measured: 1 day (Blood will be drawn from patients once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start2 Mar 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülin Öztürk Özkan, Istanbul Medeniyet University
- Investigators
- Gülin Öztürk Özkan, Assis Prof, Study chair, İstanbul Medeniyet UniversityKadir Kayataş, associate professor, Study director, Haydarpaşa Numune Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04298515
- Sponsor's protocol ID
- HNEAH-KAEK 2019/100
- Status last verified
- Feb 2020
- First submitted
- 10 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27754932Mirzaei 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.
PubMed 25470645Li 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.
PubMed 19896982
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Relationship Between Nesfatin-1 Levels and Energy Intake Levels of Patients With Type 2 Diabetes, Insulin Resistance and Obesity
- ClinicalTrials.gov ID
- NCT04298515
- Acronym / sponsor ID
- HNEAH-KAEK 2019/100
- Conditions
- Type 2 Diabetes, Insulin Resistance, Obesity, Nesfatin-1
- Keywords
- Type 2 diabetes, Insulin resistance, Obesity, Nesfatin-1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 2 Mar 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes group | Other | Diagnostic Test: Nesfatin-1In case of fasting, blood will be taken from patients for the measurement of nesfatin-1. |
| Insulin resistance group | Other | Diagnostic Test: Nesfatin-1In case of fasting, blood will be taken from patients for the measurement of nesfatin-1. |
| Obesity group | Other | Diagnostic Test: Nesfatin-1In case of fasting, blood will be taken from patients for the measurement of nesfatin-1. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes
- Insulin resistance
- Obesity disease
Key exclusion criteria (7 listed)
- Pediatric individuals
- All patients who are hospitalized,
- Liver disease
- Cancer patients
- Disease related to the gastrointestinal tract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nesfatin-1Blood will be taken from the patients on an empty stomach for measuring nesfatin-1 level | Diagnostic test | Insulin resistance group, Obesity group, Type 2 Diabetes group |
Primary outcome
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Background: PubMed 27754932Dore 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.
- Background: PubMed 25470645Mirzaei 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 publication: PubMed 19896982Li 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.
- ReviewLink provided by the sponsor.
- Original researchLink provided by the sponsor.
- Original researchLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülin Öztürk Özkan, Assis Prof study chair
İstanbul Medeniyet University
Kadir Kayataş, associate professor study director
Haydarpaşa Numune Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nesfatin-1 in people with Type 2 Diabetes and Insulin Resistance, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gülin Öztürk Özkan, Assis Prof (02162803333, glnzturk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nefratin-1 in type 2 diabetes (time frame: 1 day (Blood will be drawn from patients once)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04298515, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.