The Possible Effects of Roflumilast on Obesity Related Disorders

Sponsor
Tanta University
Study ID
NCT04800172
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
25 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    administration of roflumilast 500 mcg tablet once daily for 3 months.
  • placebo — DRUG
    administration of placebo tablet once daily for 3 months.

Study Details

Evaluation of the possible effects of roflumilast on weight, glucose and lipid metabolism, insulin resistance, oxidative stress and inflammatory process in prediabetic obese subjects.

Key Dates

Start date
May 1, 2021
Status verified
Apr 2022
Primary completion
Mar 31, 2022
Completion
Mar 31, 2022

Study Design

Enrollment
66 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Roflumilast arm
  • Placebo Comparator: Placebo arm

Primary Outcome Measure

Change in patients body weight [ Time Frame: baseline and 3 months later ]

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