Actively Recruiting
Clinical Study Evaluating the Effectiveness of Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
Led by Sherief Abd-Elsalam · Updated on 2019-04-29
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate two different drug treatments for people with nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes mellitus (DM). The study compares vildagliptin alone versus a combination of vildagliptin and metformin to see how they affect NAFLD and insulin resistance over six months. It is a phase 3 randomized clinical trial without any masking or blinding. Participants receive either vildagliptin 50 mg twice daily or a combination of vildagliptin and metformin taken twice daily as part of the study treatment. The study lasts for six months during which these medications are taken regularly. Both treatment groups are closely monitored and compared to assess their effects on liver disease and diabetes management. Throughout the study, participants will have assessments to track improvement in NAFLD and insulin resistance. The main outcome measured is the number of patients showing improvement at six months. Participants will be observed regularly for treatment effects and safety, with no mention of long-term follow-up beyond the study period.
CONDITIONS
Brief Title
Clinical Study Evaluating Vildagliptin Versus Vildagliptin/Metformin on NAFLD With DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- NAFLD and type 2 DM
You will not qualify if you...
- Viral hepatitis
- Child score more than 6
- Renal impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either vildagliptin or vildagliptin/metformin twice daily to treat NAFLD with type 2 diabetes.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, Egypt, 35111
Actively Recruiting
Research Team
S
Sherief Abd-Elsalam, ass. prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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