An assessment of the use of metformin in preventing prednisone-induced elevation in blood glucose levels among blood cancer patients at Kenyatta National Hospital

Phase 2

Recruiting

• Conditions: Nutritional, Metabolic, Endocrine

• Registration Number: PACTR201807745027158
• Lead Sponsor: ucy Ochola

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Patients currently on or are being initiated on high-dose prednisone-based chemotherapy (>30mg/day) with hematological cancers (ALL, NHL, CLL, HL and MM).
2.Patients with postprandial blood glucose readings indicating no hyperglycemia prior to enrollment in the study.
3.Patients aged 18 years and above.
4.Patient having adequate renal function prior to enrollment to the study with a serum creatinine levels of <150umol/L and/or estimated glomerular filtration rate (eGFR) of >30mL/min per 1.73m2.
5.Patients with adequate electrolyte balance particularly serum lactate levels <5 mmol/L.
6.Patients showing willingness to comply with the study protocol and have a signed informed consent.
7.Patients with normal hemoglobin reference values from full hemogram tests.

Exclusion Criteria

1.Patients on prednisone treatment for any other indication other than hematological cancers,
2.Patients with pre-existing diagnosed diabetes mellitus,
3.Patients recently exposed or awaiting radiocontrast procedures, patients with recent exposure (less than 3 months) to metformin,
4.Patients with more than one cancer where the additional cancer is non-hematological,
5.Patients on medication that may contribute to hyperglycemia like thiazide diuretics, beta-blockers, protease inhibitors, statins, niacin, phenytoin, atypical anti-psychotics, oral contraceptives and L-asparaginase,
6.Pregnant patients,
7.Patients with significant electrolyte disturbances,
8.Patients with tissue hypoxia like cardiac or respiratory insufficiencies,
9.Patients consuming three or more alcoholic drinks per day,
10.Patients with concurrent severe illness and patients currently on any other antidiabetic therapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified