Status:
NOT_YET_RECRUITING
The G Protein-Coupled Receptor Kinase Type 2 Inhibitor Paroxetine as Adjunctive Therapy to Improve Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
aya ramadan ashmawy sarhan
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-65 years
Phase:
PHASE3
Brief Summary
The aim of this study is to investigate the effect of GRK2 inhibitor paroxetine on insulin resistance in patients with type 2 diabetes mellitus.
Detailed Description
Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic disorders worldwide and its development is primarily caused by a combination of two main factors including defective insulin secreti...
Eligibility Criteria
Inclusion
- Patients with established diagnosis of type 2 diabetes.
- Patients with type 2 diabetes treated with metformin based combined oral hypoglycemic ( metformin plus DDP4 inhibitor or metformin plus sulfonylureas or metformin plus GLP-1 analogues)
- Glycated hemoglobin (HbA1c) ≥ 7% and ≤9
- Age between 20 and 65 years
- BMI ≥25 kg/m2
Exclusion
- Pregnant and lactating women
- Patients with diabetes complications except for hyperlipidemia if any.
- Patients with acute or chronic illness (such as flu, cancer, rheumatoid arthritis, etc….)
- Patients with renal impairment (S.Cr \> 1.5 mg/dl) and hepatic impairment (Bilirubin level \> 1.2 mg/dl).
- Patients with cardiovascular diseases
- Patients with condition that predispose to acidosis as COPD
- Patients with glaucoma
- Patients with thyroid disorders
- Patients on the medications that affect carbohydrate metabolism such as beta blockers, contraceptives, thiazide diuretic, corticosteroids, sympathomimetic
- Patients treated with any oral anti-diabetes agents other oral hypoglycemic agents or treated with insulin
- Patients stabilized anticoagulants, antiplatelet, antipsychotics, MAOIs, amphetamines, NSAIDs, corticosteroids, ergotamine, levothyroxine, narcotic analgesic, tramadol, liver microsomal enzyme inhibitors and liver microsomal enzyme inducers
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06203275
Start Date
January 1 2024
End Date
January 1 2026
Last Update
January 12 2024
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