Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03570632
Other study ID # PRO18050459
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date July 8, 2019
Est. completion date December 2024

Study information

Verified date October 2023
Source University of Pittsburgh
Contact Maisa N Feghali, MD
Phone 4126471000
Email feghalim@upmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Although major advancements have been made in improving glycemic management in type 1 diabetes mellitus (DM), women entering pregnancy with type 1 DM continue to be at dramatically increased risk for adverse maternal and neonatal outcomes, including hypertensive disorders of pregnancy (HDP). At present, there is a lack of effective preventive interventions for HDP, which are associated with significant maternal and neonatal morbidity and mortality. Clinical and in vitro data have shown promise for metformin in prevention of HDP in non-diabetic women. Metformin has a reassuring fetal safety profile and has been well studied in type 1 DM outside of pregnancy. The hypothesis to be tested in this application is that compared to usual care, daily oral metformin therapy initiated prior to 20 weeks' gestation in women with type 1 DM reduces the frequency of HDP.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Pregnant women 18-50 years - 12 0/7 and 19 6/7 weeks of gestation - Diagnosed with type 1 DM prior to pregnancy. Exclusion Criteria: - Known allergy or adverse reaction to metformin - Multiple gestation - Abnormal obstetrical ultrasound suspicious for major congenital abnormality, known or suspected fetal aneuploidy - Medical comorbidities that increase risk for metformin use: renal insufficiency (creatinine > 1.1 mg/dL), proteinuria (P:C >0.3 or 24-hour urine protein > 300 mg), active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes 3x above normal), inflammatory bowel disease (Crohn's and Ulcerative colitis), major hematologic disorder (including alloimmune and isoimmune thrombocytopenia).

Study Design


Intervention

Drug:
Metformin
Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy

Locations

Country Name City State
United States Magee Womens Hospital of UPMC Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Maisa N. Feghali, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Gestational weight gain At time of prenatal visits, throughout pregnancy from enrollment to delivery
Other Umbilical cord c-peptide Delivery/End of pregnancy
Other Umbilical cord glucose Delivery/End of pregnancy
Other Neonatal body composition Delivery/End of pregnancy
Primary Rate of hypertensive disorders of pregnancy Delivery/End of pregnancy
Secondary Home glucose levels throughout pregnancy Weekly, throughout pregnancy from enrollment to delivery
Secondary Birthweight Delivery/End of pregnancy
Secondary Neonatal morbidity Delivery/End of pregnancy
See also
  Status Clinical Trial Phase
Completed NCT04030091 - Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus Phase 4
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT01696266 - An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
Recruiting NCT06050642 - Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop. N/A
Completed NCT05107544 - Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes N/A
Active, not recruiting NCT04443153 - Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes N/A
Completed NCT04569994 - A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes Phase 1
Completed NCT04521634 - Glycaemic Variability in Acute Stroke
Completed NCT04089462 - Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study N/A
Completed NCT03143816 - Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study Phase 4
Completed NCT01892319 - An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
Recruiting NCT04039763 - RT-CGM in Young Adults at Risk of DKA N/A
Completed NCT04042207 - Diabeloop for Highly Unstable Type 1 Diabetes N/A
Not yet recruiting NCT06068205 - COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Recruiting NCT05909800 - Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes. Phase 2
Active, not recruiting NCT04974528 - Afrezza® INHALE-1 Study in Pediatrics Phase 3
Completed NCT04530292 - Home Intervention and Social Precariousness in Childhood Diabetes N/A
Completed NCT05428943 - OPT101 in Type 1 Diabetes Patients Phase 1
Recruiting NCT03988764 - Monogenic Diabetes Misdiagnosed as Type 1
Completed NCT05597605 - The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects N/A