Status:
TERMINATED
Metformin at the Cellular Level and Dosing for Diabetes Mellitus (DM)
Lead Sponsor:
Johns Hopkins University
Conditions:
Diabetes
Pre-diabetes
Eligibility:
All Genders
10-79 years
Phase:
NA
Brief Summary
The investigators know that metformin works at the level of the cells in the body by acting on a protein called Cyclic amine monophosphate- Response Binding Elements (CREB) binding protein or Constitu...
Detailed Description
Our studies have shown that metformin acts at the cellular level by acting on a target protein, Cyclic amine monophosphate-Response Binding Elements (CREB) binding protein or CREP Binding Protein (CBP...
Eligibility Criteria
Inclusion
- Pediatric
- Children 10-17 years.
- Both genders (male and female)
- All children must have a Primary Care Physician and/or an Endocrinologist who must be aware that the child under their care will be part of the study.
- All children must have a Primary Care Physician and/or an Endocrinologist who is considering initiating metformin therapy now or in the near future as part of standard clinical care.
- Naïve to metformin.
- Either: Prediabetic children Or diabetic children under good glycemic control
- Pediatric
Exclusion
- Children ages 10-17 who do not have parental consent and/or do not give assent
- Children living in foster care
- Children with allergies to foods in the breakfast menu
- Children who currently consume any alcohol
- Children on current antidiabetic medication or those who have been on any antidiabetic medication in the 3 months prior to enrolment
- Children with a history of /or concurrent chronic disease (eg. heart, kidney, liver disease or any type of malignancy or pre-malignant condition) that required hospitalization within the last 6 months
- Pregnancy
- Refusal by a female participant who is of child bearing potential and sexually active to use contraceptive methods such as oral contraceptive pills, barrier methods and abstinence
- Children weighing less than 36 kg
- Children with any condition that increases the risk of lactic acidosis (e.g. cancer, infection, congestive heart failure, renal disease )
- Children with history of recent hospitalization for surgery, dehydration, sepsis, hypoxemia (within the past 6 months)
- Children with history of weight loss, polyuria and polydipsia
- Children who are currently enrolled in a weight management program
- Children with known hypersensitivity to metformin
- Children with a fasting blood glucose of \>180mg/dl
- Children with a HbA1c level of ≥7%
- Children with glycosuria
- Children with clinical or laboratory evidence of hepatic disease- transaminase levels three times the upper normal range (Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)) and/or a increased level of Gamma-glutamyltransferase (GGT), Prothrombin Time (PT), International Normalized Ratio (INR) from the reference normal range and a serum albumin less than the reference normal range of the Johns Hopkins Clinical Laboratories.
- If iodinated contrast is used on a participant, due to possible acute alteration of renal function resulting in increased risk of lactic acidosis, the participant will be excluded.
- Children with renal impairment
- In children \>50kg, renal impairment is defined by a serum creatinine 1.4 mg/dl or higher in females or 1.5mg/dl or higher in males OR estimated Glomerular Filtration Rates (eGFR) ≤60mL/min by the Schwartz formula.
- In children \<50kg, renal impairment is defined by eGFR \<100 mL/min by the Schwartz formula.
- Children with acid-base disturbance as defined by serum bicarbonate levels less than 20mEq/L or greater than 29mEq/L.
- Adult Inclusion Criteria:
- Adults 18-79 years
- Both genders (male and female)
- All participants must have a Primary Care Physician and/or an Endocrinologist who must be aware that the adult under their care will be part of the study
- All participants must have a Primary Care Physician and/or an Endocrinologist who is considering initiating metformin therapy now or in the near future as part of standard clinical care.
- Naive to metformin
- EITHER: Prediabetic adults OR diabetic adults, under fair glycemic control:
- Adult
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01876992
Start Date
January 1 2012
End Date
June 1 2015
Last Update
September 26 2017
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287