A randomized open parallel controlled study for reversing diabetes by reducing liver fat deposition

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025357

Enrollment

Unknown

Registered

2019-08-24

Start date

2019-10-01

Completion date

Unknown

Last updated

2019-08-27

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

Conditions

type 2 diabetes

Interventions

Test group:basic medication + Dapagliflozin

Control group:basic medication + Acarbose

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subject: Non-alcoholic fatty liver disease with type 2 diabetes; 2. Metformin treatment for three months is not ideal; 3. C peptide >= 2ng / ml; 4. Male or female, aged >= 18, and 7.0%; 6. The subject signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Known or suspected of being allergic to test drugs or to control drugs. 2. Women who are currently pregnant or planning to ship during the study period are currently in lactating women. 3, Patients with acute metabolic diabetes complications, diabetes insipidus. 4. There are obvious hepatobiliary diseases in the clinic. These include, but are not limited to, chronic active hepatitis and/or severe hepatic insufficiency. ALT or AST increased >3 times normal upper limit or serum total bilirubin >2 mg/dL. 5. With a rapid progression of renal disease, end-stage renal disease (eGFR 1800mg / g, male subjects serum creatinine > 133umol / L, female subjects serum creatinine > 124umol/L 6. Poorly controlled severe hypertension, that is, SBP >= 180mmHg and or DBP >= 110mmHg; SBP < 95mmHg patients. 7. Myocardial infarction, cardiac surgery, stable angina, grade III or IV heart failure within 6 months before receiving basic treatment. 8. Gastrointestinal disease or surgical history including: severe hernia, intestinal obstruction, intestinal ulcer, gastrointestinal anastomosis, intestinal resection. 9. Malignant tumors occur within five years. 10. Those with low immune function. 11. History of severe osteoporosis and secondary fractures. 12. Alcohol abuse or abuse of other drugs within 6 months prior to receiving basic treatment.

Design outcomes

Primary

Measure	Time frame
Glycated hemoglobin;Liver fat content;	—

Secondary

Measure	Time frame
Fasting blood sugar;C Peptide;Liver function;Renal function;Triglycerides;Total cholesterol;Intestinal flora;	—

Countries

China

Contacts

Public ContactYangang Wang

The Affiliated Hospital of Qingdao University

wangyg1966@126.com+86 18661807293

Outcome results

None listed

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