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Effect of weight loss combined with glycemic management on the incidence of diabetes in patients with obese and prediabetes--a multi-centre randomized clinical trial

Effect of weight loss combined with glycemic management on the incidence of diabetes in patients with obese and prediabetes--a multi-centre randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102418
Enrollment
Unknown
Registered
2025-05-14
Start date
2023-09-06
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Diabetes

Interventions

Weight loss + glycemic management:Lifestyle interventions (diet and exercise guidance) combined with oral hypoglycemic drugs (acarbose or metformin according to their glycemia)
Weight loss intervention:Lifestyle interventions (diet and exercise guidance)

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1)18 = 28kg/m^2. (3) Prediabetes diagnosed according to the 1999 WHO criteria: including impaired fasting glucose (6.1 = 7.8 mmol/L, but < 11.1 mmol/L; fasting glucose < 7.0 mmol/L). (4) Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Diabetes mellitus diagnosed according to the WHO 1990 criteria; (2) Patients with secondary obesity (e.g., hypothyroidism, Cushing's syndrome, etc.); (3) Mental illness or history of medication use for related disorders; (4) Drug or alcohol abusers diagnosed according to DSM-IV; (5) Received weight loss or treatments to decrease glycemia, lipidemia, or hepatoprotective cure, or other hormonal medications within 6 months prior to the study; (6) Comorbid with coagulation dysfunction; severe diseases of heart, liver, kidney and other important organs (severe hepatic impairment refers to: ALT, AST >= 5 times the upper limit value for 2 consecutive times in the last 6 months; moderate and severe renal insufficiency (CKD stage 3 or above), eGFR less than 60 (CKD-EPI formula); heart failure NYHA stage III-IV); (7) With uncontrollable hypertension or symptomatic hypotension; (8) Treated or untreated malignancy within 5 years; (9) Acute infectious disease in the last 1 month; (10) Pregnant or lactating women and those are preparing for pregnancy; (11) unable to fully understand possible risks and benefits of the study; (12) Any other risk factors that may affect the efficacy or safety of this study.

Design outcomes

Primary

MeasureTime frame
5-year incidence of diabetes;

Secondary

MeasureTime frame
glucose metabolism, Insulin resistance, islet ß -cell function;lipid metabolism;cardiac function assessment;pulmonary function assessment;quality of life assessment;physical examination;body composition;Liver fat content;UACR;

Countries

P.R.China

Contacts

Public ContactYanming Chen

The Third Affiliated Hospital of Sun Yat-sen University

chyanm@mail.sysu.edu.cn+86 189 2210 2818

Outcome results

None listed

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