PreDiabetesNCT05035966
Association of β-amyloid 40 and 42 With Prediabetes
An observational study of PreDiabetes, run by Liegang Liu.
Trial summary
Background: Previous epidemiological and animal studies have suggested a strong relationship between prediabetes and Alzheimer's disease. Recently, we demonstrated that plasma β-amyloid (Aβ), a potential biomarker for Alzheimer's disease, was elevated in individuals with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Plasma β-amyloid 40 and 42 concentration
- How many people
- 1,442 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2012to 30 Jun 2020
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All the participants enrolled were of Chinese Han ethnicity. They gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation.
Who may be able to join
- Age ≥30 and ≤80 years, BMI <40 kg/m2, screened for prediabetes or diabetes, and with enough plasma collected for β-amyloid 40 and 42 detection.
Who cannot join
- History of diabetes mellitus and prediabetes, pharmacological treatment for hyperlipidaemia, any clinically systemic disease, any acute illness, chronic inflammatory disease or any infective disease.
About this study
Official title: Association of Plasma β-amyloid 40 and 42 With Risk of Prediabetes
Background: Previous epidemiological and animal studies have suggested a strong relationship between prediabetes and Alzheimer's disease. Recently, we demonstrated that plasma β-amyloid (Aβ), a potential biomarker for Alzheimer's disease, was elevated in individuals with type 2 diabetes. However, few studies have investigated the associations of plasma Aβ40 and Aβ42 concentrations with prediabetes.
Objective: we aimed to investigate the associations of plasma Aβ40 and Aβ42 concentrations with risk of prediabetes in two independent studies.
Design: We performed a case-control study and a nested case-control study within a prospective cohort study. In the case-control study, we included 571 newly diagnosed individuals with prediabetes and 571 control participants. Prediabetes individuals were consecutively recruited from subjects who attended the outpatient clinics of Department of Endocrinology at Tongji Medical College Hospital from 2012 to 2015. Concomitantly, we recruited healthy controls from a general population undergoing a routine health checkup in the same hospital. One healthy control was selected at random for each prediabetes individuals according to age (±3 years) and sex. The inclusion criteria of participants were as follows: age ≥30 and ≤80 years, BMI <40 kg/m2, no history of prediabetes and diabetes mellitus, no history of receiving pharmacological treatment for hyperlipidemia, nor any clinically systemic disease, any acute illness, and chronic inflammatory or any infective disease. An independent nested case-control study was conducted within an ongoing cohort study, namely the Tongji-Ezhou cohort. Briefly, 5533 participants, including 3101 retired employees and 2432 working employees, were enrolled from Echeng Stell and received healthcare for a baseline investigation between 2013 and 2015. The first follow-up for all participants was finished by mid-2020. Considering the low incidence of prediabetes among young working employees, we performed the nested case-control study among retired employees. During the follow-up, 119 new-onset prediabetes cases were diagnosed within the retired employees according to fasting plasma glucose. We randomly selected the control participants who matched 2:1 to the cases by age (±3 years) and sex from the retired employees with normal fasting plasma glucose. The inclusion criteria were the same as the case-control study; 2 new-onset prediabetes cases aged >80 years were excluded. Additionally, 17 cases without enough plasma were excluded. Finally, 100 individuals with new-onset prediabetes and 200 well-matched control participants were included for the analysis of the nested case-control study. These two studies were approved by the Ethics and Human Subject Committee of Tongji Medical College. All enrolled participants in the two studies were of Chinese Han ethnicity and provided informed written consent. Plasma Aβ40 and Aβ42 concentrations were simultaneously measured by validated assay platforms from Meso Scale Discovery (MSD; Rockville, MD, USA).
- Conditions
- PreDiabetes
- Being tested
- Plasma β-amyloid 40 and 42 concentration
- Keywords
- β-amyloid 40, β-amyloid 42, prediabetes
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma β-amyloid 40 and 42 concentrationOther
Plasma β-amyloid 40 and 42 concentrations were simultaneously measured by validated assay platforms from Meso Scale Discovery (MSD; Rockville, MD, USA).
| Study group | Role | What they receive |
|---|---|---|
| Prediabetes | In the case-control study, prediabetes was diagnosed according to the diagnostic criteria recommended by the WHO in 1999. Prediabetes was defined as impaired fasting glucose (FPG ≥6.1 mmol/L and <7.0 mmol/L, and 2-h post-glucose load <7.8 mmol/L) and/or impaired glucose tolerance (FPG <6.1 mmol/L, and 2-h post-glucose load ≥7.8 mmol/L and <11.1 mmol/L). In the nested case-control study, new-onset prediabetes was defined as FPG ≥6.1 mmol/L and <7.0 mmol/L. Receives: Other: Plasma β-amyloid 40 and 42 concentration | |
| Healthy control | In the case-control study, healthy control was defined as FPG <6.1 mmol/L and 2-h post-glucose load <7.8 mmol/L. In the nested case-control study, healthy control was defined as FPG <6.1 mmol/L. Receives: Other: Plasma β-amyloid 40 and 42 concentration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediabetes
In the case-control study, prediabetes was diagnosed in accordance with the diagnostic criteria recommended by WHO in 1999; in the nested case-control study, new-onset prediabetes was confirmed as FPG ≥7.0 mmol/l.
Measured: Newly diagnosed prediabetes in the case-control study was diagnosed between 2012 and 2015; new-onset prediabetes in the nested case-control study was identified between 2013 and 2020.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Jan 2012
- Primary completion31 Dec 2015
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liegang Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liegang Liu, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035966
- Sponsor's protocol ID
- XBP20210903
- Status last verified
- Sep 2021
- First submitted
- 3 Sep 2021
- Last updated
- 9 Sep 2021
- 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 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Plasma β-amyloid 40 and 42 With Risk of Prediabetes
- ClinicalTrials.gov ID
- NCT05035966
- Acronym / sponsor ID
- XBP20210903
- Conditions
- PreDiabetes
- Keywords
- β-amyloid 40, β-amyloid 42, prediabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,442 participants (actual)
- Lead sponsor
- Liegang LiuUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 5 Sep 2021 (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.
Background: Previous epidemiological and animal studies have suggested a strong relationship between prediabetes and Alzheimer's disease. Recently, we demonstrated that plasma β-amyloid (Aβ), a potential biomarker for Alzheimer's disease, was elevated in individuals with type 2 diabetes. However, few studies have investigated the associations of plasma Aβ40 and Aβ42 concentrations with prediabetes.
Objective: we aimed to investigate the associations of plasma Aβ40 and Aβ42 concentrations with risk of prediabetes in two independent studies.
Design: We performed a case-control study and a nested case-control study within a prospective cohort study. In the case-control study, we included 571 newly diagnosed individuals with prediabetes and 571 control participants. Prediabetes individuals were consecutively recruited from subjects who attended the outpatient clinics of Department of Endocrinology at Tongji Medical College Hospital from 2012 to 2015. Concomitantly, we recruited healthy controls from a general population undergoing a routine health checkup in the same hospital. One healthy control was selected at random for each prediabetes individuals according to age (±3 years) and sex. The inclusion criteria of participants were as follows: age ≥30 and ≤80 years, BMI <40 kg/m2, no history of prediabetes and diabetes mellitus, no history of receiving pharmacological treatment for hyperlipidemia, nor any clinically systemic disease, any acute illness, and chronic inflammatory or any infective disease. An independent nested case-control study was conducted within an ongoing cohort study, namely the Tongji-Ezhou cohort. Briefly, 5533 participants, including 3101 retired employees and 2432 working employees, were enrolled from Echeng Stell and received healthcare for a baseline investigation between 2013 and 2015. The first follow-up for all participants was finished by mid-2020. Considering the low incidence of prediabetes among young working employees, we performed the nested case-control study among retired employees. During the follow-up, 119 new-onset prediabetes cases were diagnosed within the retired employees according to fasting plasma glucose. We randomly selected the control participants who matched 2:1 to the cases by age (±3 years) and sex from the retired employees with normal fasting plasma glucose. The inclusion criteria were the same as the case-control study; 2 new-onset prediabetes cases aged >80 years were excluded. Additionally, 17 cases without enough plasma were excluded. Finally, 100 individuals with new-onset prediabetes and 200 well-matched control participants were included for the analysis of the nested case-control study. These two studies were approved by the Ethics and Human Subject Committee of Tongji Medical College. All enrolled participants in the two studies were of Chinese Han ethnicity and provided informed written consent. Plasma Aβ40 and Aβ42 concentrations were simultaneously measured by validated assay platforms from Meso Scale Discovery (MSD; Rockville, MD, USA).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prediabetes | – | Other: Plasma β-amyloid 40 and 42 concentrationIn the case-control study, prediabetes was diagnosed according to the diagnostic criteria recommended by the WHO in 1999. Prediabetes was defined as impaired fasting glucose (FPG ≥6.1 mmol/L and <7.0 mmol/L, and 2-h post-glucose load <7.8 mmol/L) and/or impaired glucose tolerance (FPG <6.1 mmol/L, and 2-h post-glucose load ≥7.8 mmol/L and <11.1 mmol/L). In the nested case-control study, new-onset prediabetes was defined as FPG ≥6.1 mmol/L and <7.0 mmol/L. |
| Healthy control | – | Other: Plasma β-amyloid 40 and 42 concentrationIn the case-control study, healthy control was defined as FPG <6.1 mmol/L and 2-h post-glucose load <7.8 mmol/L. In the nested case-control study, healthy control was defined as FPG <6.1 mmol/L. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All the participants enrolled were of Chinese Han ethnicity. They gave informed written consent to the study and did not take any medication known to affect glucose tolerance or insulin secretion before participation.
Key inclusion criteria (1 listed)
- Age ≥30 and ≤80 years, BMI <40 kg/m2, screened for prediabetes or diabetes, and with enough plasma collected for β-amyloid 40 and 42 detection.
Key exclusion criteria (1 listed)
- History of diabetes mellitus and prediabetes, pharmacological treatment for hyperlipidaemia, any clinically systemic disease, any acute illness, chronic inflammatory disease or any infective disease.
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 |
|---|---|---|
| Plasma β-amyloid 40 and 42 concentrationPlasma β-amyloid 40 and 42 concentrations were simultaneously measured by validated assay platforms from Meso Scale Discovery (MSD; Rockville, MD, USA). | Other | Healthy control, Prediabetes |
Primary outcome
Prediabetes
Time frame: Newly diagnosed prediabetes in the case-control study was diagnosed between 2012 and 2015; new-onset prediabetes in the nested case-control study was identified between 2013 and 2020.
In the case-control study, prediabetes was diagnosed in accordance with the diagnostic criteria recommended by WHO in 1999; in the nested case-control study, new-onset prediabetes was confirmed as FPG ≥7.0 mmol/l.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes, run by Liegang Liu.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediabetes (time frame: Newly diagnosed prediabetes in the case-control study was diagnosed between 2012 and 2015; new-onset prediabetes in the nested case-control study was identified between 2013 and 2020.). 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 9 Sep 2021.