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Observation of the effect and safety of exenatide on hepatic biomarkers in elderly patients with type 2 diabetes complicated nonalcoholic fatty liver disease

Observation of the effect and safety of exenatide on hepatic biomarkers in elderly patients with type 2 diabetes complicated nonalcoholic fatty liver disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPC-15006339
Enrollment
Unknown
Registered
2015-04-27
Start date
2015-05-20
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

type 2 diabetes complicated nonalcoholic fatty liver disease

Interventions

Groop Exenatide:Exenatide was initiated at 5 mcg twice daily while stopping their pre-study oral hypoglycemic drugs or taking them at reduced dose, titrated to 10 mcg twice daily after one month
Groop Glargine:Glargine was started with 0.1IU/kg once-daily at bedtime while continuing their pre-study oral hypoglycemic drugs, and titrated with glucose levels

Sponsors

Metabolic Disease Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Elderly patients with type 2 diabetes (age 60~75 years); 2. Diagnosis of fatty liver by ultrasound; 3. Inadequate glycaemic control (FPG: 8.0-11.0 mmol/L and/or HbAlc: 7.5%-10.0%); 4. Alanine aminotransferase and aspartate aminotransferase twice below the upper normal limit.

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes or secondary diabetes; 2. With severe acute or chronic diabetes complications; 3. Clinically significant haematologic, oncologic, renal, cardiac, hepatic or gastrointestinal disease; 4. Any history of liver disease including metabolic or auto-immune liver disease or viral hepatitis; 5. Weekly alcohol intake >14 units for women or >21 units for men.

Design outcomes

Primary

MeasureTime frame
markers of hepatic function;the controlled attenuation parameter (CAP);glycosylated hemoglobin;fasting plasma glucose.;postprandial plasma glucose;

Secondary

MeasureTime frame
blood lipid;

Countries

China

Contacts

Public ContactGUANYUE
guanyue@medmail.com.cn+86 13612199277

Outcome results

None listed

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