Clinical trial NCT06296836: Effect of Continuing Versus Holding Metformin During Hospitalizations.
Official title: Effect of Continuing Versus Holding Metformin During Hospitalizations to Internal Medicine on Glucose Control, Acidosis, Abdominal Symptoms, Length of Stay, and Mortality.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel, prospective trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean glucose levels
timeFrame: During hospitalization
Secondary outcomes:
measure: Incidence of hyperglycemia greater than 300 mg/dl.
timeFrame: During hospitalization
measure: Incidence of hypoglycemia (Glu = 54 - 70).
timeFrame: During hospitalization
measure: Incidence of moderate hypoglycemia (Glu < 54)
timeFrame: During hospitalization
measure: Incidence of severe hypoglycemia (Glu < 54 with symptoms)
timeFrame: During hospitalization
measure: Mean lactic acid levels.
timeFrame: During hospitalization
measure: Incidence of lactic acid levels greater than 2.0.
timeFrame: During hospitalization
measure: Mean anion gap.
timeFrame: During hospitalization
measure: Incidence of anion gap > 11
timeFrame: During hospitalization
measure: Incidence of elevated lactic acid level or anion gap.
timeFrame: During hospitalization
measure: Incidence of inadvertently not continuing metformin on discharge
timeFrame: At discharge
measure: GI adverse effects
timeFrame: Within 3 days of discharge
measure: Mortality
timeFrame: 30 +/- 3 days after discharge
Other outcomes:
measure: Mean glucose levels while receiving metformin in the continuation arm and while not receiving metformin in the discontinuation arm
timeFrame: During hospitalization
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References: