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Effect of Hydroxychloroquine on glucose fluctuation in type 2 diabetes patient

Effects of Add-On Treatment with Hydroxychloroquine on Glucose Fluctuations in Indian Type 2 Diabetes Patients Receiving Insulin with other oral therapy.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2018/06/014394
Enrollment
40
Registered
2018-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes

Interventions

Intervention1: Hydroxychloroquine 400 mg oralyy once daily for 3 month: 400 mg tablet orally for one day for 3 month type 2 diabetes patients

Sponsors

Dr Arjun Baidya
Lead Sponsor
Astha Clinic
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: patients who are admitted to private hospital for hyperglycemia and during their hospitalization has achieved target glycemic control (7-9%) with Insulin and other oral therapy (Which include metformin, sulphonylureas, glinides, thiazolidine, DPP4i and alpha-glucosidase inhibitors). Treatment with insulin therapy, including once-daily basal insulin, twice-daily premixed insulin therapy, or multiple daily insulin therapy, for at least 2 weeks. Daily insulin dosage Patients with ideal body weight > 60 kg Compliance Patient able to understand and willing to fully comply with study procedures and restrictions. Patients ready to undergo a follow-up period of 9 days.

Exclusion criteria

Exclusion criteria: Patients with a history of any retinopathy of any grade including diabetic retinopathy, evidence of an imminent need for retinal laser therapy, uncorrected visual acuity Patients with history of myalgia, aplastic anemia or agranulocytosis, granulocytopenia, psoriasis, porphyria, rash, scaling, scaling eczema, and G6PD deficiency. Patients with significant cardiovascular illness limiting participation of patient in a clinical trial Patients with abnormal renal function (Serum Cr >1.5 mg/dL, BUN > 20 mg/dL). Patients with abnormal liver function (AST and ALT, total bilirubin or alkaline phosphatase > 2.5 times the upper limit of normal values). Patients with dementia or other cognitive impairment prohibiting informed consent. Patients with disease of blood or haematopoetic organs Patients with known history of HIV 1 or HIV 2, Hepatitis B or C Viruses or syphilis infection or malignancy. Pregnant or lactating women Women of childbearing potential not practicing contraception

Design outcomes

Primary

MeasureTime frame
10 days trial to measure mean amplitude of glycemic excursions (MAGE) over 1 weeks. 24-h mean (SD) glucose levels, mean amplitude of glycemic excursions, rates of proportions of appropriate glucose levels (70â??140 mg/dL), hyperglycemia (140 mg/dL), and hypoglycemia (70 mg/dL), total area under the curve (AUC) within 2 h after each meal, and postprandial glucose levels within 2 h after each meals using 24-h glycemic data from CGM.Timepoint: 10 Days

Secondary

MeasureTime frame
Levels of serum glycated albumin (GA), 1,5-anhydro-dglucitol (1,5-AG), and high-sensitivity C-reactive protein (hsCRP)Timepoint: 10 Days

Countries

India

Contacts

Public ContactDr Nihar Ranjan Bhattacharya

D.H.L.T. Kolkata

nihardhlt@rediffmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026