Effect of Continuing Versus Holding Metformin During Hospitalizations.
- Registration Number
- NCT06296836
- Lead Sponsor
- University of Illinois at Chicago
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Adult (18+ years of age)
- Admitted to an internal medicine service.
- On Metformin prior to admission.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin continuation Metformin Continuation of home metformin regimen during hospitalization to an internal medicine service
- Primary Outcome Measures
Name Time Method Mean glucose levels During hospitalization Average of daily glucose levels during hospitalization
- Secondary Outcome Measures
Name Time Method Incidence of hyperglycemia greater than 300 mg/dl. During hospitalization Glucose \> 300
Incidence of hypoglycemia (Glu = 54 - 70). During hospitalization Glu = 54 - 70
Incidence of moderate hypoglycemia (Glu < 54) During hospitalization Glu \< 54
Incidence of severe hypoglycemia (Glu < 54 with symptoms) During hospitalization Glu \< 54 with symptoms
Mean lactic acid levels. During hospitalization Mean lactic acid levels
Incidence of lactic acid levels greater than 2.0. During hospitalization Lactic acid \> 2.0
Mean anion gap. During hospitalization Mean anion gap, a calculated value
Incidence of anion gap > 11 During hospitalization Anion Gap \> 11
Incidence of elevated lactic acid level or anion gap. During hospitalization Lactic acid \> 2.0 or Anion Gap \> 11
Incidence of inadvertently not continuing metformin on discharge At discharge Transitions of care
GI adverse effects Within 3 days of discharge GI side effects after discharge
Mortality 30 +/- 3 days after discharge Mortality as determined via chart search and follow up phone call
Trial Locations
- Locations (1)
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States