The G Protein-Coupled Receptor Kinase Type 2 Inhibitor Paroxetine as Adjunctive Therapy to Improve Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus

NCT06203275 | Unknown Phase 3

• 1 other identifier: paroxetine in type 2 diabetes
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

GRK2 inhibitor; insulin resistance; diabetes; paroxetine

Outcome Measures

Primary Outcomes (2)

• The primary outcome is the change in glycated Hemoglobin (HbA1c).

  3 months

• Change in HOMA-IR .

  3 months

Secondary Outcomes (1)

• The secondary outcome is the change in expression of GRK2

  3 months

Study Arms (2)

group 1 (control group)

PLACEBO COMPARATOR

which will receive metformin based combined oral hypoglycemic plus placebo tablets

Drug: Placebo

group II (intervention group)

ACTIVE COMPARATOR

which will receive metformin based combined oral hypoglycemic plus 12.5 mg paroxetine daily at morning.

Drug: Paroxetine

Interventions

Paroxetine DRUG

intervention group n=22 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) plus paroxetine 12.5 mg daily

group II (intervention group)

Placebo DRUG

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) plus placebo daily

group 1 (control group)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• aya ramadan ashmawy sarhan: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance; Diabetes Mellitus

Interventions

Paroxetine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: tanta

Model Details: This proof of concept pilot study is designed as a randomized placebo controlled parallel trial. Forty four patients of both gender with confirmed diagnosis of T2DM will be randomized using sealed envelope method into two groups

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: January 12, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: January 12, 2024

Record last verified: 2023-11