- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07582471
Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus
Comparison of the Outcome of Insulin Versus Oral Hypoglycemic Agents in Gestational Diabetes Mellitus
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
A prevalent problem among pregnant women, gestational diabetes mellitus (GDM) typically manifests in the second and third trimesters. However, the reported frequency of GDM also varies globally due to variations in GDM diagnosis criteria. GDM raises the risk of harmful prenatal complications for both the mother and the fetus because of poorly managed blood glucose. Nonetheless, the application of more stringent criteria for the diagnosis of GDM (IADPSG criteria) is advised due to the recent advancements in our understanding of the condition, which will help with blood glucose control during pregnancy. Women are recommended to use diet and exercise to control their blood glucose levels after receiving a diagnosis of GDM. However, hypoglycemic medications like as insulin, metformin, glyburide, and in certain trials, acarbose, should be used for people who are unable to regulate their blood glucose.
When lifestyle changes are not successful, insulin has been the recommended treatment for GDM since it regulates blood glucose levels without passing through the placenta. The needs of each patient can be met by combining and matching formulations of short- and long-acting insulin. As treatments for GDM, oral hypoglycemic drugs such glyburide and metformin are becoming more and more well-liked. Metformin decreases the liver's production of glucose and increases insulin sensitivity, both of which result in lower blood glucose levels.6Gluburide encourages the pancreas to secrete more insulin. Despite being convenient and well-tolerated, there has been much debate and research over the safety and efficacy of oral administration during pregnancy.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Punjab Province
-
Lodhran, Punjab Province, Pakistan
- Shahida Islam Teaching Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Every woman with a cephalic presentation of singleton pregnancy (as determined by ultrasonography) with gestational diabetes mellitus.
- A gestational age greater than 24 weeks (measured on LMP).
- Age range: 18-45.
- Parity 0-5
Exclusion Criteria:
- Expectant mothers who already have chronic diabetes mellitus.
- Women for whom oral hypoglycemics are contraindicated.
- Underlying conditions such severe chronic hypertension, thyroid illness, chronic renal insufficiency, and hepatic disease that are known to impact fetal growth or medication clearance.
- A history of insulin or metformin hypersensitivity
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: insulin
those in group B will get insulin (Humulin R) subcutaneously whose dose can be adjusted within 24 hours according to blood sugar levels, whereas those in group A will receive 500 mg tablets of metformin twice daily orally
|
those in group B will get insulin (Humulin R) subcutaneously whose dose can be adjusted within 24 hours according to blood sugar levels, whereas those in group A will receive 500 mg tablets of metformin twice daily orally
|
|
Placebo-jämförare: oral hypoglycemic group
For glycemic control and dosage modification, serum sugar levels will be checked on a regular basis.
Blood glucose levels will be monitored after a fast, one hour after eating, and two hours after eating.
Patients in which sugar cannot be controlled, then ward protocol can be followed for sugar control
|
For glycemic control and dosage modification, serum sugar levels will be checked on a regular basis.
Blood glucose levels will be monitored after a fast, one hour after eating, and two hours after eating.
Patients in which sugar cannot be controlled, then ward protocol can be followed for sugar control
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
percentage of neonatal hypoglycemia
Tidsram: 24 hours
|
neonatal glucose values <30 mg/dl on two consecutive occasions within 24 hour of birth as measured by glucometer
|
24 hours
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: mudassar pansota, Associate Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Sjukdomar i det endokrina systemet
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Metaboliska sjukdomar
- Graviditetskomplikationer
- Störningar i glukosmetabolism
- Diabetes mellitus
- Hyperinsulinism
- Närings- och metabola sjukdomar
- Diabetes, graviditet
- Insulinresistens
- Hormoner
- Hormoner, hormonsubstitut och hormonantagonister
- Peptidhormoner
- Peptider
- Aminosyror, peptider och proteiner
- Insuliner
- Bukspottkörtelhormoner
- Proinsulin
- Insulin
Andra studie-ID-nummer
- Shahida Islam hospital
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