Multifactorial Intervention on Diabetes (MIDiab Study)
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|ClinicalTrials.gov Identifier: NCT03430284|
Recruitment Status : Recruiting
First Posted : February 12, 2018
Last Update Posted : September 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: Lifestyle therapy Drug: Pharmacotherapy Other: Monitoring and management Other: General treatment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Multifactorial Intervention on Type 2 Diabetes - A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
|Experimental: Integrated Treatment||
Behavioral: Lifestyle therapy
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.
Pharmacological therapy is individualized. 1.Glucose-lowering agents:
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
(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.
Other: Monitoring and management
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.
Other: General treatment
General treatment is carried out based on the device from the general practitioners at present.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03430284
|Contact: Xu Houemail@example.com|
|Shandong Provincial Hospital||Not yet recruiting|
|Jinan, Shandong, China, 250021|
|Contact: Shanshan Shao +8653168776094 firstname.lastname@example.org|
|Shandong Provincial Hospital||Recruiting|
|Jinan, Shandong, China|
|Study Chair:||Jiajun Zhao, MD,PhD||Shandong Provincial Hospital|