Type2 DiabetesNCT05525884
Mechanism of Serum PRL in the Development of MAFLD
An observational study of Type2 Diabetes and Fatty Liver, Nonalcoholic, run by Shen Qu at 1 site in China.
Trial summary
Metabolic associated fatty liver disease (MAFLD) has currently reached a worldwide epidemic. Serum PRL levels within or outside physiological range have been found to affect metabolic homeostasis differently. However, the relationship between serum PRL and MAFLD among diabetic patients is unclear. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type2 Diabetes, Fatty Liver, Nonalcoholic, Liver Fibrosis
- What is being tested?
- non-invasive method, Fibroscan
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Jan 2024
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with T2DM who met the inclusion and criteria criteria were consecutively enrolled.
Who may be able to join
- aged 18~65 years old,
- underwent the laboratory tests, hepatic ultrasonography, and valid transient elastography (FibroScan) examination
Who cannot join
- other known chronic liver diseases, such as chronic hepatitis B or C, autoimmune hepatitis, and haemochromatosis
- pre-existing active cancer, renal dysfunction, severe liver dysfunction, congestive heart failure or free abdominal fluid
- history of hyperthyroidism or hypothyroidism, pituitary diseases, and other types of diabetes
- significant alcohol consumption
- pregnancy
- receiving any therapeutic methods that could lead to liver steatosis or fibrosis, influence the glucolipid metabolism, or PRL levels, such as lipid-lowering, and PRL-lowering agents (bromocriptine) within 6 months prior to this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Shen Qu, PHD, +8613636600255, qushencn@hotmail.com
About this study
Metabolic associated fatty liver disease (MAFLD) has currently reached a worldwide epidemic. Serum PRL levels within or outside physiological range have been found to affect metabolic homeostasis differently. However, the relationship between serum PRL and MAFLD among diabetic patients is unclear. The investigators aimed to explore the association between serum PRL and the risk of MAFLD in patients with type 2 diabetes (T2DM).
- Conditions
- Type2 Diabetes, Fatty Liver, Nonalcoholic, Liver Fibrosis
- Being tested
- non-invasive method, Fibroscan
- Keywords
- Type 2 Diabetes, Metabolic associated fatty liver disease,, Prolactin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive method, FibroscanOther
Liver Ultrasound and transient elastography (FibroScan®)
| Study group | Role | What they receive |
|---|---|---|
| MAFLD and Non-MAFLD | Not described Receives: Other: non-invasive method, Fibroscan | |
| Steatosis and Non-Steatosis | Not described Receives: Other: non-invasive method, Fibroscan | |
| Fibrosis and Non-Fibrosis | Not described Receives: Other: non-invasive method, Fibroscan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of MAFLD proposed by the international expert consensus statement in 2020
MAFLD was diagnosed based on evidence of ultrasonically diagnosed hepatic steatosis in addition to one of the three criteria proposed by the international expert consensus statement in 2020, namely overweight/obesity, T2DM, or metabolic dysregulation regardless of alcohol consumption or other concomitant liver diseases. Metabolic dysregulation was defined by the presence of at least two metabolic risk abnormalities found in lean or normal weight patients, including hypertension, dyslipidemia, hyperglycemia, IR, and high CRP levels.
Measured: 2019-2024
PRL
serum prolactin levels
Measured: 2019-2024
High PRL (HP)
HP was defined as serum PRL ≥ 324mIU/L in males or ≥ 496mIU/L in females according to the normal reference value of serum PRL in our hospital.
Measured: 2019-2024
Normal PRL (NP)
NP was defined as serum PRL < 324mIU/L in males or < 496mIU/L in females.
Measured: 2019-2024
Diagnosis of hepatic steatosis
Those who have hepatic steatosis if CAP value ≥ 248 dB/m, which was obtained from transient elastography (FibroScan®) using the M probe or the XL probe.
Measured: 2019-2024
Diagnosis of significant hepatic fibrosis
those who have significant hepatic fibrosis if LSM ≥ 7.0 kPa and ≥ 6.2 kPa (using either M or XL probes)
Measured: 2019-2024
Secondary outcomes (8)
Homeostasis model assessment of IR (HOMA-IR)
HOMA-IR was calculated as described by Matthews et al: FPG (mmol/L) × FINS (mU/L) /22.5.
Measured: 2019-2024
Hypertension
it was defined by blood pressure ≥130/85mmHg or antihypertensive drugs.
Measured: 2019-2024
Dyslipidemia
it was defined by plasma TG ≥ 1.7mmol/L in the total population or plasma HDL-C < 1.0 mmol/L for men and < 1.3 mmol/L for women, or specific drug treatment.
Measured: 2019-2024
Overweight or obesity
it was defined as BMI ≥ 23 kg/m2 in Asians.
Measured: 2019-2024
Abdominal obesity
It was diagnosed when WC ≥ 90/80 cm in Asian men and women.
Measured: 2019-2024
T2DM
it was diagnosed according to the guideline for the prevention and treatment of T2DM in China (2020 edition)
Measured: 2019-2024
High CRP
plasma CRP > 2 mg/L
Measured: 2019-2024
High HOMA-IR
HOMA-IR≥ 2.5
Measured: 2019-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Jan 2017
- Primary completion1 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shen Qu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shen Qu, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525884
- Sponsor's protocol ID
- PRL
- Status last verified
- Sep 2022
- First submitted
- 15 Dec 2021
- Last updated
- 2 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Serum PRL in the Development of MAFLD
- ClinicalTrials.gov ID
- NCT05525884
- Acronym / sponsor ID
- PRL
- Conditions
- Type2 Diabetes, Fatty Liver, Nonalcoholic, Liver Fibrosis
- Keywords
- Type 2 Diabetes, Metabolic associated fatty liver disease,, Prolactin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Shen QuUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 2 Sep 2022 (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.
Metabolic associated fatty liver disease (MAFLD) has currently reached a worldwide epidemic. Serum PRL levels within or outside physiological range have been found to affect metabolic homeostasis differently. However, the relationship between serum PRL and MAFLD among diabetic patients is unclear. The investigators aimed to explore the association between serum PRL and the risk of MAFLD in patients with type 2 diabetes (T2DM).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAFLD and Non-MAFLD | – | Other: non-invasive method, Fibroscan |
| Steatosis and Non-Steatosis | – | Other: non-invasive method, Fibroscan |
| Fibrosis and Non-Fibrosis | – | Other: non-invasive method, Fibroscan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with T2DM who met the inclusion and criteria criteria were consecutively enrolled.
Key inclusion criteria (2 listed)
- aged 18~65 years old,
- underwent the laboratory tests, hepatic ultrasonography, and valid transient elastography (FibroScan) examination
Key exclusion criteria (6 listed)
- other known chronic liver diseases, such as chronic hepatitis B or C, autoimmune hepatitis, and haemochromatosis
- pre-existing active cancer, renal dysfunction, severe liver dysfunction, congestive heart failure or free abdominal fluid
- history of hyperthyroidism or hypothyroidism, pituitary diseases, and other types of diabetes
- significant alcohol consumption
- pregnancy
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 |
|---|---|---|
| non-invasive method, FibroscanLiver Ultrasound and transient elastography (FibroScan®) | Other | Fibrosis and Non-Fibrosis, MAFLD and Non-MAFLD, Steatosis and Non-Steatosis |
Primary outcome
Diagnosis of MAFLD proposed by the international expert consensus statement in 2020
Time frame: 2019-2024
MAFLD was diagnosed based on evidence of ultrasonically diagnosed hepatic steatosis in addition to one of the three criteria proposed by the international expert consensus statement in 2020, namely overweight/obesity, T2DM, or metabolic dysregulation regardless of alcohol consumption or other concomitant liver diseases. Metabolic dysregulation was defined by the presence of at least two metabolic risk abnormalities found in lean or normal weight patients, including hypertension, dyslipidemia, hyperglycemia, IR, and high CRP levels.
PRL
Time frame: 2019-2024
serum prolactin levels
High PRL (HP)
Time frame: 2019-2024
HP was defined as serum PRL ≥ 324mIU/L in males or ≥ 496mIU/L in females according to the normal reference value of serum PRL in our hospital.
Normal PRL (NP)
Time frame: 2019-2024
NP was defined as serum PRL < 324mIU/L in males or < 496mIU/L in females.
Diagnosis of hepatic steatosis
Time frame: 2019-2024
Those who have hepatic steatosis if CAP value ≥ 248 dB/m, which was obtained from transient elastography (FibroScan®) using the M probe or the XL probe.
Diagnosis of significant hepatic fibrosis
Time frame: 2019-2024
those who have significant hepatic fibrosis if LSM ≥ 7.0 kPa and ≥ 6.2 kPa (using either M or XL probes)
8 secondary outcomes
Homeostasis model assessment of IR (HOMA-IR)
Time frame: 2019-2024
Hypertension
Time frame: 2019-2024
Dyslipidemia
Time frame: 2019-2024
Overweight or obesity
Time frame: 2019-2024
Abdominal obesity
Time frame: 2019-2024
T2DM
Time frame: 2019-2024
High CRP
Time frame: 2019-2024
High HOMA-IR
Time frame: 2019-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes and Fatty Liver, Nonalcoholic, run by Shen Qu at 1 site in China.
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 2 inclusion and 6 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 2 Sep 2022. 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 China. 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 Shen Qu (+862166301064, qushencn@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of MAFLD proposed by the international expert consensus statement in 2020 (time frame: 2019-2024). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2022.