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NCT06296836 Clinical Trial

Effect of Continuing Versus Holding Metformin During Hospitalizations.

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Effect of Continuing Versus Holding Metformin During Hospitalizations to Internal Medicine on Glucose Control, Acidosis, Abdominal Symptoms, Length of Stay, and Mortality.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06296836
Other study ID # 2024-001
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date April 1, 2024
Est. completion date June 30, 2026

Study information
Verified date February 2024
Source University of Illinois at Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized study of continuing versus holding metformin during hospitalizations to internal medicine services to determine the effects on glucose control, acidosis, abdominal symptoms, length of stay, and mortality.

Description:

The purpose of this study is to determine what the effects of the routine practice of holding metformin in hospitalized patients with type 2 diabetes are on outcomes. The objectives of this study are to determine how holding versus continuing metformin during hospitalization to an internal medicine service affects the incidences of lactic acidosis, mean anion gap, mean glucose levels, low and very high blood sugars, GI effects after discharge, lack of continuation of metformin upon discharge, mean glucose levels, lengths of stay, and 30-day mortality.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date June 30, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 110 Years
Eligibility Inclusion Criteria: - Adult (18+ years of age) - Admitted to an internal medicine service. - On Metformin prior to admission. Exclusion Criteria: - Inability to take oral medications - eGFR < 30 ml/min/1.73 m2 - Dialysis - Current Acidosis (pH < 7.35) including diabetic ketoacidosis - Child-Turcotte-Pugh class C hepatic cirrhosis - Acute Decompensated Heart Failure - Cognitively impaired and/or unable to consent - Lack of or unwillingness to share contact information - Pregnant women

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Metformin
Continuation of home metformin

Locations
Country Name City State
United States University of Illinois at Chicago Chicago Illinois

Sponsors (9)
Lead Sponsor Collaborator
University of Illinois at Chicago Annesti Elmasri, Avisek Datta, Colin Goodman, Dulal Bhaumik, Emily Hanners, Hailey Soni, Julie Jun, Peggy Choye

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm Mean daily glucose levels will only be included for the days in which the subjects received or did not receive metformin as per their assigned arm. During hospitalization
Primary Mean glucose levels Average of daily glucose levels during hospitalization During hospitalization
Secondary Incidence of hyperglycemia greater than 300 mg/dl. During hospitalization
Secondary Incidence of hypoglycemia (Glu = 54 - 70). During hospitalization
Secondary Incidence of moderate hypoglycemia (Glu < 54) During hospitalization
Secondary Incidence of severe hypoglycemia (Glu < 54 with symptoms) During hospitalization
Secondary Mean lactic acid levels. During hospitalization
Secondary Incidence of lactic acid levels greater than 2.0. During hospitalization
Secondary Mean anion gap. During hospitalization
Secondary Incidence of anion gap > 11 During hospitalization
Secondary Incidence of elevated lactic acid level or anion gap. During hospitalization
Secondary Incidence of inadvertently not continuing metformin on discharge At discharge
Secondary GI adverse effects Within 3 days of discharge
Secondary Mortality 30 +/- 3 days after discharge
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