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Clinical study on the treatment of obesity combined with glucose metabolism disorders by Chinese medicine combined with low-carbonated hydrate diet therapy

Clinical study on the treatment of obesity combined with glucose metabolism disorders by Chinese medicine combined with low-carbonated hydrate diet therapy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063857
Enrollment
Unknown
Registered
2022-09-19
Start date
2022-09-19
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Metabolic Diseases

Interventions

Group 1:Chinese medicine combined with a low-carb diet
Group 2:Low carbon diet alone
Group 3:Chinese medicine combined with conventional diChinese medicine combined with conventional dietet
Group 4:Regular Diet

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Referring to the Guidelines for the Prevention and Control of Overweight and Obesity in Chinese Adults published in 2003, overweight or obese patients with 24 = BMI = 35 Kg/m2; combined with disorders of glucose metabolism, referring to the criteria of the Chinese Guidelines for the Prevention and Control of Type 2 Diabetes 2017 edition, the blood glucose range: fasting blood glucose 6.1-11 mmol/l or 2h postprandial or random blood glucose 7.8-16 mmol/l, and glycosylated hemoglobin 6.5%-10.0%. Pre-study, subjects who had not used glucose-lowering drugs were not allowed to use glucose-lowering drugs during the study period; pre-study, subjects who were on stable use of glucose-lowering, lipid-lowering, antihypertensive and other chronic disease drugs could still be enrolled, but it was ensured that they were not allowed to use additional glucose-lowering drugs during the study period. 2. age: =18 years and =70 years. 3. those without ketosis occurring within 3 months of onset and not yet on insulin therapy. 4. those who signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with secondary obesity. 2. type 1 diabetes mellitus; type 2 diabetes mellitus patients with fasting glucose >11 mmol/l or 2h postprandial or random glucose >16 mmol/l or glycated hemoglobin >10.0%. 3. acute or severe chronic complications of diabetes such as diabetic ketosis or ketoacidosis, hyperosmolarity, or lactic acidosis. 4. recurrent episodes of severe hypoglycemia. 5. AST and ALT > 3 times the upper limit of normal; moderate to severe renal insufficiency (eGFR < 60 ml/min/1.73 m2 according to MDRD). 6. clinically significant cardiovascular disease episodes, including myocardial infarction, arrhythmia, conduction block with electrocardiographic manifestations (second degree type I and above), unstable angina or congestive heart failure (NYHA class III-IV). 7. pregnancy or planned pregnancy. 8. Possible hypersensitivity to the study drug or severe intestinal absorption dysfunction. 9. Those who cannot strictly comply with the requirements of the study and consciously cooperate with the study (meaning those who cannot cooperate with dietary control or cannot take the medication as prescribed and affect the efficacy). 10. Psychiatric patients.

Design outcomes

Primary

MeasureTime frame
Body weight;

Countries

China

Contacts

Public ContactSongWei

Guangdong Hospital of Traditional Chinese Medicine

weiweiwindy@gzucm.edu.cn13926001008

Outcome results

None listed

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