Effect of Hydroxychloroquine on glucose fluctuation in type 2 diabetes patient

Phase 4

Recruiting

Conditions: Health Condition 1: null- Type 2 Diabetes

Registration Number: CTRI/2018/06/014394

Lead Sponsor: Dr Arjun Baidya

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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 <= 60 Units per day.

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

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 <20/100, abnormal visual fields, difficulty to examine optic disc, or evidence of retinal pigment epithelial abnormalities and patients with history or risk of macular edema.

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures