GLP-1；Metformin；Telomere-telomerase System；Par-4Phase 4Par-4；GLP-1NCT02535299
Par-4 and Telomere-telomerase System in Type 2 Diabetes Patients Who Received GLP-1 or Metformin Treatment
A Phase 4 study testing Liraglutide and Metformin in people with GLP-1；Metformin；Telomere-telomerase System；Par-4, run by Third Military Medical University at 1 site in China.
Trial summary
Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and Par-4. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- GLP-1；Metformin；Telomere-telomerase System；Par-4
- What is being tested?
- Liraglutide and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2019
- Phase
- Phase 4
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Newly dignosised type 2 diabetes according to WHO criteria.glycated hemoglobin (HbA1c) was more than 10%;
- Seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD);
Who cannot join
- Type 1 diabetes mellitus,presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and GAD；
- Gestational diabetes;
- patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southwest Hospital of the Third Military Medical University
Chongqing, Chongqing Municipality, 400038
wu qi nan, doctor, 13452867542 ext. +86, wqn11@126.com
chen bing, doctor, 68754138 ext. +86, chenbing3@medmail.com.cn
About this study
Official title: The Correlation Between Par-4 and Telomere-telomerase System in the New Dignosised Type 2 Diabetes Patients Who Received GLP-1 Analog or Metformin Treatment
Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and Par-4.
Read the detailed description
160 Type 2 diabetes in our hospital will divide into 4 groups: group A (40 healthy volunteers), group B (40 patients who give basal and insulin treatment, group C（40 patients who give basal and Liraglutide treatment),group D（40 patients who give basal and metformin treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, telomere length,telomerase activity will record respectively. And High-sensitive C-reactive protein (HsCRP), Par-4, GST,SOD,GSH-PX,ATF-6,CHOP,XBP-1 and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.
- Being tested
- Liraglutide, Metformin
- Keywords
- telomere-telomerase, Par-4, GLP-1, metformin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Also called Victoza
GLP-1 analog (1.2mg-1.8mg/day) treatment for 6 months
MetforminDrug
Also called Glucophage
Metformin(1500mg-2000mg/day) treatment for 6 months
| Study group | Role | What they receive |
|---|---|---|
| insulin | Experimental | basic insulin treatment：glargine 10-30 units once a day based on the glucose control for 6 months. Receives: Drug: Liraglutide; Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter:glycosylated hemoglobin A1c
up to 6 months;;HbA1c was measured by a certified hospital laboratory according to established and approved protocols
Measured: up to 6 months;
Secondary outcomes (4)
physiological parameter:the concentration of Par-4
up to 6 months;;secretary Par-4 were detected with Par-4 ELISA kit (MBL, USA)
Measured: up to 6 months;
physiological parameter:telomere length
up to 6 months;;Telomere length was measured via fluorescence in situ hybridization using flow cytometry
Measured: up to 6 months;
physiological parameter:telomease activity
up to 6 months;;Telomerase activity was measured using the TeloTAGGG Telomerase PCR ELISAPLUS kit (Roche Diagnostics, Mannheim, Germany)
Measured: up to 6 months;
physiological parameter:TNF-α
up to 6 months, TNF-a levels were measured by commercial ELISA kit following the manufacturer's instructions;TNF-a levels were measured by commercial ELISA kit following the manufacturer's instructions;(MBL, USA)
Measured: up to 6 months;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJun 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP-1；Metformin；Telomere-telomerase System；Par-4Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Qinan, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535299
- Sponsor's protocol ID
- GLP-1
- Acronym
- Par-4；GLP-1
- Status last verified
- Sep 2016
- First submitted
- 21 Aug 2015
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Par-4 and Telomere-telomerase System in the New Dignosised Type 2 Diabetes Patients Who Received GLP-1 Analog or Metformin Treatment
- ClinicalTrials.gov ID
- NCT02535299
- Acronym / sponsor ID
- Par-4；GLP-1 / GLP-1
- Keywords
- telomere-telomerase, Par-4, GLP-1, metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 Aug 2015 (estimated)
- 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.
Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and Par-4.
Detailed description
160 Type 2 diabetes in our hospital will divide into 4 groups: group A (40 healthy volunteers), group B (40 patients who give basal and insulin treatment, group C（40 patients who give basal and Liraglutide treatment),group D（40 patients who give basal and metformin treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, telomere length,telomerase activity will record respectively. And High-sensitive C-reactive protein (HsCRP), Par-4, GST,SOD,GSH-PX,ATF-6,CHOP,XBP-1 and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insulin | Experimental | Drug: Liraglutide, Drug: Metforminbasic insulin treatment：glargine 10-30 units once a day based on the glucose control for 6 months. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly dignosised type 2 diabetes according to WHO criteria.glycated hemoglobin (HbA1c) was more than 10%;
- Seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD);
Key exclusion criteria (3 listed)
- Type 1 diabetes mellitus,presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and GAD；
- Gestational diabetes;
- patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular 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 |
|---|---|---|
| LiraglutideAlso: VictozaGLP-1 analog (1.2mg-1.8mg/day) treatment for 6 months | Drug | insulin |
| MetforminAlso: GlucophageMetformin(1500mg-2000mg/day) treatment for 6 months | Drug | insulin |
Primary outcome
physiological parameter:glycosylated hemoglobin A1c
Time frame: up to 6 months;
up to 6 months;;HbA1c was measured by a certified hospital laboratory according to established and approved protocols
4 secondary outcomes
physiological parameter:the concentration of Par-4
Time frame: up to 6 months;
physiological parameter:telomere length
Time frame: up to 6 months;
physiological parameter:telomease activity
Time frame: up to 6 months;
physiological parameter:TNF-α
Time frame: up to 6 months;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
- Individual participant dataSharing planned: Undecided
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.
Southwest Hospital of the Third Military Medical University
Chongqing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide and Metformin in people with GLP-1；Metformin；Telomere-telomerase System；Par-4, run by Third Military Medical University 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 3 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 13 Sep 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological parameter:glycosylated hemoglobin A1c (time frame: up to 6 months;). 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 13 Sep 2016.