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Role of Neural and Hormonal Regulation Factors on Insulin Secretion After Gastric Bypass Surgery Vroege fase 1 160

Rekruterend
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De klinische studie NCT00992901 onderzoekt overige bij Post Bariatricsurgery, Hypoglykemie. Deze Vroege fase 1 interventioneel-studie heeft de status rekruterend. Het doel is om 160 deelnemers te includeren vanaf 1 oktober 2009. De studie wordt geleid door The University of Texas Health Science Center at San Antonio en de voltooiing is gepland op 1 augustus 2027. Laatste update op ClinicalTrials.gov: 9 september 2025.
Beknopte samenvatting
RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are ...Toon meer
Uitgebreide beschrijving
RYGB (roux-en-y gastric bypass) has been reported to reverse type 2 diabetes (T2DM) immediately after surgery before any significant weight loss. In addition, a growing number of patients have been recognized with life-threatening hyperinsulinemic hypoglycemia several years following their surgery. While the mechanisms by which RYGB improves glucose metabolism or alters islet cell function in patients after RYGB are ...Toon meer
Officiële titel

Hormonal and Neural Control of Insulin Secretion Following Gastric Bypass Surgery

Aandoeningen
Post BariatricsurgeryHypoglykemie
Andere studie-ID's
  • 18-070H
  • DK083554 (Ander subsidie-/financieringsnummer) (NIDDK)
NCT-ID
NCT00992901
Startdatum (Werkelijk)
2009-10
Laatste update geplaatst
2025-09-09
Verwachte einddatum
2027-08
Inschrijving (Geschat)
160
Studietype
Interventioneel
FASE
Vroege fase 1
Status
Rekruterend
Trefwoorden
gastric bypass surgery
glucose tolerance
Insulin response to meal ingestion
Gut hormone and neural response to meal ingestion
Primaire doel
Overige
Toewijzing
Niet-gerandomiseerd
Interventiemodel
Cross-over
Blindering
Geen (Open-label)
Armen / Interventies
Deelnemersgroep/StudiearmInterventie/Behandeling
ExperimenteelExendin-(9-39)
To evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
Exendin-(9-39)
A physiological study to evaluate the role of GLP-1 signaling in glucose tolerance and insulin secretion
Experimenteelatropine
To evaluate the effect of neural activation on insulin secretion and glucose metabolism
Atropine
A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism
ExperimenteelGLP-1 and GIP
to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones
GLP-1 and GIP
A physiological study to evaluate the beta-cell sensitivity to different doses of exogenous gut hormones
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Gut hormones and neural signaling contribution to insulin secretion rate and glucose tolerance
Each study of the protocol is conducted up to seven hours with data collected at intervals specific to the individual study procedure.
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
Accepteert gezonde vrijwilligers
Ja
  • Hypoglycemic RYGB patients with documented blood glucose level <50 mg/dl
  • Asymptomatic individuals with bariatric surgery
  • Healthy non-surgical patients with no personal history of diabetes
  • Subjects must physically be able to come to our clinical research center at Cedars-Sinai Medical Center

  • Active heart, lung, liver, gastrointestinal or kidney disease; unable to give informed consent; pregnancy; uncontrolled high blood pressure or high cholesterol; significant anemia (hemoglobin <11g/dL); prisoners or institutionalized individuals; type 2 diabetes melitis; development of any serious medical or psychiatric illness during recruitment or studies;
  • RYGB patients will also be disqualified if they have gastric outlet obstruction or severe diarrhea
  • Healthy non-surgical patients with personal history of diabetes

For administration of atropine, the following exclusions also apply:

  • History of glaucoma
  • Uncontrolled hypertension (any subjects with BP>140/90 and history of dyslipidemia
  • Taking any medication that might interact with atropine and cannot be stopped will be excluded from the study)
  • Myasthenia gravis
  • Brain pathology
  • Enlarged prostate in men
The University of Texas Health Science Center at San Antonio logoThe University of Texas Health Science Center at San Antonio
Centraal Contactpersoon
Contact: Marzieh Salehi, MD MS, 210-567-6691, [email protected]
Contact: Jennifer Foster, MSN, 210-450-8696, [email protected]
2 Studielocaties in 1 landen

Texas

Texas Diabetes Institute - University Health System, San Antonio, Texas, 78207, United States
Jennifer Foster, MSN, Contact, 210-450-8696, [email protected]
Marzieh Salehi, MD, MS, Contact, 210-567-6691, [email protected]
Marzieh Salehi, Hoofdonderzoeker
Rekruterend
South Texas Veterans Health Care System, San Antonio, Texas, 78229, United States
Marzieh Salehi, Contact, 210-567-6691, [email protected]
Jennifer Foster, MSN, Contact, 210-450-8696, [email protected]
Marzieh Salehi, MD, MS, Hoofdonderzoeker
Rekruterend