NCT03430284

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,300

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2018

Longer than P75 for phase_4 diabetes-mellitus-type-2

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

3.8 years

First QC Date

January 22, 2018

Last Update Submit

July 5, 2021

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes MellitusDiabetic Vascular ComplicationsMultifactorial InterventionDigital and Network Management

Outcome Measures

Primary Outcomes (3)

  • Integrated management rate of multiple risk factor in type 2 diabetes

    Multiple risk factor: plasma glucose, blood pressure, serum lipid profiles and obesity

    30 months

  • Incidence of diabetic vascular complications

    Diabetic vascular complications: both macrovascular and microvascular complications

    30 months

  • Control rate of diabetes and diabetic vascular complications

    30 months

Secondary Outcomes (5)

  • Carotid intima-media thickness (IMT)

    30 months

  • Ankle brachial index (ABI)

    30 months

  • Urine albumin creatinine ratio (UACR)

    30 months

  • Estimated glomerular filtration rate (eGFR)

    30 months

  • Stage of diabetic retinopathy evaluated by fundus photograph

    30 months

Study Arms (2)

Integrated Treatment

EXPERIMENTAL
Behavioral: Lifestyle therapyDrug: PharmacotherapyOther: Monitoring and management

General Treatment

OTHER
Other: General treatment

Interventions

Lifestyle therapyBEHAVIORAL

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.

Integrated Treatment
PharmacotherapyDRUG

Pharmacological 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.

Integrated Treatment
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.

Integrated Treatment
General treatmentOTHER

General treatment is carried out based on the device from the general practitioners at present.

General Treatment

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old;
  • diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetic Angiopathies

Interventions

Drug TherapyTherapeutics

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Officials

  • Jiajun Zhao, MD,PhD

    Shandong Provincial Hospital

    STUDY CHAIR

Central Study Contacts

Xu Hou

CONTACT

+861515328565515153285655@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2018

First Posted

February 12, 2018

Study Start

April 1, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2022

Last Updated

July 9, 2021

Record last verified: 2021-07

Locations

CN(2)