Multicenter Research of Early Intervention for Adult Metabolic Syndrome in Beijing Region

Endocrine and Metabolic Research

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-08000099

Enrollment

Unknown

Registered

2008-08-14

Start date

2008-06-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic syndrome

Interventions

Metformin group:Life style intervention + Metformin

Controlled group:Life style intervention + placebo: Metformin placebo tablets are given in 100 patients, and Pioglitazone placebo tablets are given in another 100 patients

Pioglitazone group:Life style intervention + placebo

Eligibility

Sex/Gender

Male

Age

30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Aged between 30 and 70 years old; Patients that have knowledge of the trial's process, participate voluntarily and sign informed contents; Central obesity: waist circumference >=90 cm in males or >=80 cm in females and combining with at least 2 of the follows: 1.7mmol/L <= TG <5.65mmol/L, and TC <7.0mmol/L; 5.6mmol/L <= FPG <7.0mmol/L; newly diagnosis of diabetes with FPG <=8.0mmol/L; 130mmHg <= systolic blood pressure <160mmHg, and / or 85mmHg <=diastolic blood pressure <100mmHg, or being treated by antihypertension agents; HDL-C<1.03mmol/L in males, or<1.29mmol/L in females.

Exclusion criteria

Exclusion criteria: Pregnant or breast-feeding women or females preparing for pregnancy; Patients that cannot cooperate; Systolic blood pressure >=160mmHg, and/or diastolic blood pressure >=100mmHg; Patients with organic heart diseases such as frequent episodes of angina pectoris, heart dysfunction, cardiac dilation, myocardial infarction within half a year, severe arrhythmia, or being treated by CABG or PCI; Stroke, transient ischemic attack; impaired hepatic function, ALT or AST level higher than 2 times of normal range; Impaired renal function, serum creatinine = 133 mmol/L in females or = 135 mmol/L in males; Chronic gastrointestinal diseases; Combined with chronic or acute infection, malignant tumor, mental disorders, drugs or alcohol addiction patients; Allergic to the drugs used in the trial or having contraindication; edema; Use of antiobesity drug.

Design outcomes

Primary

Measure	Time frame
Changes of common carotid artery intima-media thickness;Incidence of diabetes;	—

Secondary

Measure	Time frame
Incidence of cardio-cerebrovascular events;Mortality;	—

Contacts

Public ContactWenying Yang

ywy_1010@yahoo.com.cn+86 010 84205716

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026