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Effect of Empagliflozin on Metabolic Outcomes in Adults Living With HIV Receiving Dolutegravir-Based Therapy

ConditionsMetabolic SyndromeObesity & OverweightHIV (Human Immunodeficiency Virus)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbdelrahman Mahmoud

About this trial

We investigate the role of empagliflozin in the treatment of obesity in PLWH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >18 years up to 65 years old.

Body Mass Index (BMI) > 30 kg/m².

Currently receiving an integrase strand transfer inhibitor (INSTI)-based regimen (dolutegravir-based ART).

Sustained virologic suppression, defined as HIV-1 RNA < 200 copies/mL for at least 6 months.

Disqualifiers

Diagnosis of Diabetes Mellitus, defined as a fasting blood glucose level > 126 mg/dL or glycated hemoglobin (HbA1c) > 6.5% (or per ADA definition).

Renal impairment (e.g., eGFR < 60 ml/min/1.73m²).

Active viral hepatitis B or C.

Hypersensitivity to empagliflozin or any of its excipients.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin (oral)

    Drug

    Empagliflozin is an oral medication used primarily to treat type 2 diabetes. It belongs to a class of drugs called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors). Empagliflozin blocks SGLT2 proteins in the kidneys. This prevents glucose reabsorption, causing excess sugar to be excreted in urine. It helps lower blood sugar levels and can also reduce body weight and blood pressure.

  • Placebo

    Drug

    TDF/FTC+DLG

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Control GroupPlacebo comparator 1 intervention
Group B: EMPA Group + SOCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Weight change

Weight will be measured in kilograms using a calibrated scale from baseline to 6 months in PLWH on dolutegravir-based antiretroviral therapy.

Time frame
6 months

Secondary outcomes

1

Change in Total Cholesterol

Effects of empagliflozin versus placebo on Concentration of total cholesterol in serum, measured in mg/dL.

Time frame
6 months
2

Change in Fasting Blood Glucose

Concentration of glucose in blood plasma, measured in mg/dL after a minimum 8-hour overnight fast.

Time frame
6 months
3

Change in Glycated Hemoglobin (HbA1c)

The percentage of glycated hemoglobin in the blood, used as an indicator of long-term glycemic control.

Time frame
6 months
4

Change in Serum Creatinine

Concentration of creatinine in the blood, measured in mg/dL

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abdelrahman Mahmoud

Lead sponsor

Cairo University

Sponsor institution

Source ClinicalTrials.gov
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