Diabetes Mellitus, Type 2Phase 4NCT03430284
Multifactorial Intervention on Diabetes (MIDiab Study)
A Phase 4 study testing Lifestyle therapy, Pharmacotherapy and Monitoring and management in people with Diabetes Mellitus, Type 2, run by Shandong Provincial Hospital at 2 sites in China.
Trial summary
The prevalence of diabetes mellitus has been increasing in recent decades in China, and vascular complication is the major burden in patients with type 2 diabetes. Previous studies demonstrated that only glycemic control was not effective enough to prevent or improve diabetic vascular complications, but guidelines… Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Lifestyle therapy, Pharmacotherapy and Monitoring and management
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,300 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2018to 31 Dec 2022
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35-75 years old;
- diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.
Who cannot join
- type 1 diabetes，specific types of diabetes，gestational diabetes or pregestational diabetes;
- acute cardiovascular or cerebrovascular accidents within past 3 months;
- severe hepatic or renal dysfunction;
- malignant tumor;
- allergic history or contraindication for any drugs in trials;
- taking part in other clinical trials;
- obviously poor compliance.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Shanshan Shao, +8653168776094, shaoshanshan11@126.com
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
About this study
Official title: Effects of Multifactorial Intervention on Type 2 Diabetes - A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.
The prevalence of diabetes mellitus has been increasing in recent decades in China, and vascular complication is the major burden in patients with type 2 diabetes. Previous studies demonstrated that only glycemic control was not effective enough to prevent or improve diabetic vascular complications, but guidelines from the Chinese Diabetes Society and other national guidelines recommend an integrated multifactorial treatment approach. In this study, we aim to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy and periodical monitoring in patients with type 2 diabetes.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Lifestyle therapy, Pharmacotherapy, Monitoring and management, General treatment
- Keywords
- Type 2 Diabetes Mellitus, Diabetic Vascular Complications, Multifactorial Intervention, Digital and Network Management
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle therapyBehavioural
The key components of lifestyle therapy include medical nutrition therapy, regular physical activity, sufficient amounts of sleep, behavioral support, and smoking cessation and avoidance of all tobacco products.
PharmacotherapyDrug
Pharmacological therapy is individualized. 1.Glucose-lowering agents:
- Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors
- GLP-1 receptor agonist
- Insulin:Rapid-acting analogs;Short-acting analogs;Intermediate-acting analogs;Basal insulin analogs;Premixed insulin products
2.Blood pressure-lowering agents
(1)ACE inhibitor;(2)Angiotensin receptor blockers (ARBs);(3)Calcium channel blockers (CCB);(4)Diuretics;(5)β-blockers;(6)α1-blockers
3.Lipid-modifying agents
(1)Statins;(2)Fibrates;(3)Others: Nicotinic Acid, Ezetimibe,Probucol,Bile Acid Sequestrants,Policosanol,etc.
4.Medications for weight management
(1)Glucose-lowering agents associated with weight loss;(2)Orlistat;(3)Metabolic Surgery
The above medications are individualized to maintain the risk factors (blood glucose, serum lipid profiles, blood pressure and weight) at appropriate levels.
Monitoring and managementOther
Before follow-up, patients are divided into low, moderate or high risk for diabetic vascular complications. During follow-up, frequencies of interview and risk factor monitoring are formulated based on the risk stratification.
General treatmentOther
General treatment is carried out based on the device from the general practitioners at present.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Treatment | Experimental | Not described Receives: Behavioral: Lifestyle therapy; Drug: Pharmacotherapy; Other: Monitoring and management |
| General Treatment | Other | Not described Receives: Other: General treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Integrated management rate of multiple risk factor in type 2 diabetes
Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity
Measured: 30 months
Incidence of diabetic vascular complications
Diabetic vascular complications: both macrovascular and microvascular complications
Measured: 30 months
Control rate of diabetes and diabetic vascular complications
Measured: 30 months
Secondary outcomes (5)
Carotid intima-media thickness (IMT)
Measured: 30 months
Ankle brachial index (ABI)
Measured: 30 months
Urine albumin creatinine ratio (UACR)
Measured: 30 months
Estimated glomerular filtration rate (eGFR)
Measured: 30 months
Stage of diabetic retinopathy evaluated by fundus photograph
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- The Affiliated Hospital of Qingdao University, The First Hospital of Jilin University, The First People's Hospital of Yinchuan, Beijing Hospital, National Center of Gerontology, The First Affiliated Hospital of Air Force Medical University, Inner Mongolia People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Fujian Medical University Union Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Yantai Yuhuangding Hospital
- Responsible party
- Principal investigator, Jia-jun Zhao, Shandong Provincial Hospital
- Investigators
- Jiajun Zhao, MD,PhD, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430284
- Sponsor's protocol ID
- 2017YFC1309800
- Status last verified
- Jul 2021
- First submitted
- 22 Jan 2018
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multifactorial Intervention on Type 2 Diabetes - A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.
- ClinicalTrials.gov ID
- NCT03430284
- Acronym / sponsor ID
- 2017YFC1309800
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 Diabetes Mellitus, Diabetic Vascular Complications, Multifactorial Intervention, Digital and Network Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,300 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Collaborators
- The Affiliated Hospital of Qingdao University, The First Hospital of Jilin University, The First People's Hospital of Yinchuan, Beijing Hospital, National Center of Gerontology, The First Affiliated Hospital of Air Force Medical University, Inner Mongolia People's Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Fujian Medical University Union Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Yantai Yuhuangding Hospital
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Feb 2018 (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.
The prevalence of diabetes mellitus has been increasing in recent decades in China, and vascular complication is the major burden in patients with type 2 diabetes. Previous studies demonstrated that only glycemic control was not effective enough to prevent or improve diabetic vascular complications, but guidelines from the Chinese Diabetes Society and other national guidelines recommend an integrated multifactorial treatment approach. In this study, we aim to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy and periodical monitoring in patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Treatment | Experimental | Behavioral: Lifestyle therapy, Drug: Pharmacotherapy, Other: Monitoring and management |
| General Treatment | Other | Other: General treatment |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 35-75 years old;
- diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.
Key exclusion criteria (7 listed)
- type 1 diabetes，specific types of diabetes，gestational diabetes or pregestational diabetes;
- acute cardiovascular or cerebrovascular accidents within past 3 months;
- severe hepatic or renal dysfunction;
- malignant tumor;
- allergic history or contraindication for any drugs in trials;
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 |
|---|---|---|
| Lifestyle therapyThe key components of lifestyle therapy include medical nutrition therapy, regular physical activity, sufficient amounts of sleep, behavioral support, and smoking cessation and avoidance of all tobacco products. | Behavioural | Integrated Treatment |
| PharmacotherapyPharmacological therapy is individualized. 1.Glucose-lowering agents: 1. Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors 2. GLP-1 receptor agonist 3. Insulin:Rapid-acting analogs;Short-acting analogs;Intermediate-acting analogs;Basal insulin analogs;Premixed insulin products 2.Blood pressure-lowering agents (1)ACE inhibitor;(2)Angiotensin receptor blockers (ARBs);(3)Calcium channel blockers (CCB);(4)Diuretics;(5)β-blockers;(6)α1-blockers 3.Lipid-modifying agents (1)Statins;(2)Fibrates;(3)Others: Nicotinic Acid, Ezetimibe,Probucol,Bile Acid Sequestrants,Policosanol,etc. 4.Medications for weight management (1)Glucose-lowering agents associated with weight loss;(2)Orlistat;(3)Metabolic Surgery The above medications are individualized to maintain the risk factors (blood glucose, serum lipid profiles, blood pressure and weight) at appropriate levels. | Drug | Integrated Treatment |
| Monitoring and managementBefore follow-up, patients are divided into low, moderate or high risk for diabetic vascular complications. During follow-up, frequencies of interview and risk factor monitoring are formulated based on the risk stratification. | Other | Integrated Treatment |
| General treatmentGeneral treatment is carried out based on the device from the general practitioners at present. | Other | General Treatment |
Primary outcome
Integrated management rate of multiple risk factor in type 2 diabetes
Time frame: 30 months
Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity
Incidence of diabetic vascular complications
Time frame: 30 months
Diabetic vascular complications: both macrovascular and microvascular complications
Control rate of diabetes and diabetic vascular complications
Time frame: 30 months
5 secondary outcomes
Carotid intima-media thickness (IMT)
Time frame: 30 months
Ankle brachial index (ABI)
Time frame: 30 months
Urine albumin creatinine ratio (UACR)
Time frame: 30 months
Estimated glomerular filtration rate (eGFR)
Time frame: 30 months
Stage of diabetic retinopathy evaluated by fundus photograph
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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.
Jiajun Zhao, MD,PhD study chair
Shandong Provincial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lifestyle therapy, Pharmacotherapy and Monitoring and management in people with Diabetes Mellitus, Type 2, run by Shandong Provincial Hospital at 2 sites 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 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 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Xu Hou (+8615153285655, 15153285655@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrated management rate of multiple risk factor in type 2 diabetes (time frame: 30 months). 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?
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 Jul 2021.