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Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03494868
Recruitment Status : Enrolling by invitation
First Posted : April 11, 2018
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
Emily E. Sharpe, M.D., Mayo Clinic

Brief Summary:
Preoperative fasting and surgery can cause metabolic stress and insulin resistance. Oral carbohydrate loading has been shown to attenuate the development of insulin resistance in the non-pregnant population undergoing many different types of surgery. Pregnant women have an increase in insulin resistance and therefore may further benefit from a preoperative carbohydrate load prior to cesarean delivery. Although woman in the UK receive a carbohydrate drink prior to elective cesarean delivery, the metabolic effects of these drinks on the mother and neonate have not been evaluated.

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Dietary Supplement: Carbohydrate Drink Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity
Actual Study Start Date : March 13, 2019
Estimated Primary Completion Date : November 20, 2020
Estimated Study Completion Date : November 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Fasting
Fasting prior to elective cesarean section delivery (standard of care)
Experimental: Carbohydrate Drink
Subjects will drink 2 carbohydrate drinks prior to elective cesarean section delivery
Dietary Supplement: Carbohydrate Drink
2 - 12 oz drinks
Other Name: Clearfast Preop Drink




Primary Outcome Measures :
  1. Oral glucose tolerance test [ Time Frame: 24 hours postoperatively ]
    glucose, insulin



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • ASA physical status II-III women presenting for scheduled, elective cesarean delivery under neuraxial anesthesia
  • Singleton gestation at term (37-42 weeks)
  • Ages 18-50

Exclusion:

  • Preexisting diabetes (Gestational diabetes, Type I DM, Type II DM)
  • Taking insulin-sensitizing or other medications known to influence glucose or fatty acid metabolism.
  • Kidney, heart, or liver disease. Severe lipid disorders.
  • History of bariatric surgery
  • Pre-pregnancy BMI >40
  • Prolonged period of time (>4 hours) between ingestion of carbohydrate drink and surgery
  • Four or more repeat cesarean sections

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494868


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Emily E Sharpe, MD Mayo Clinic
Additional Information:
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Responsible Party: Emily E. Sharpe, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03494868    
Other Study ID Numbers: 16-009567
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases