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

Primary Purpose

Insulin Sensitivity

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbohydrate Drink
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Sensitivity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Fasting

Carbohydrate Drink

Arm Description

Fasting prior to elective cesarean section delivery (standard of care)

Subjects will drink 2 carbohydrate drinks prior to elective cesarean section delivery

Outcomes

Primary Outcome Measures

Oral glucose tolerance test
glucose, insulin

Secondary Outcome Measures

Full Information

First Posted
April 4, 2018
Last Updated
April 13, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03494868
Brief Title
Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity
Official Title
Preoperative Oral Carbohydrate Drink for Elective Cesarean Delivery and the Effect on Insulin Sensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
need additional funding
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Preoperative fasting and surgery can cause metabolic stress and insulin resistance. Perioperative insulin resistance results in hyperglycemia which can lead to increased infectious complications, morbidity, and mortality.2,3 Significant research has occurred in the non-pregnant population utilizing preoperative oral carbohydrate loading to attenuate the development of insulin resistance. In a recent meta-analysis, Awad and colleagues 2 found that a preoperative carbohydrate drink may be associated with reduced length of stay and a reduction in postoperative insulin resistance in patients undergoing major abdominal surgery. Approximately 1.3 million women undergo cesarean delivery (CD) annually in the United States. 4 CD is the most common inpatient surgery in the United States. In the UK, there are recommendations to implement enhanced recovery after obstetric surgery. Implementation of enhanced recovery supports the National Health Service Quality, Innovation, Productivity, and Prevention programme with the aim of improving quality of care while reducing costs. As part of the enhanced recovery pathway, pregnant women are receiving a preoperative carbohydrate drink. There is a paucity of research looking at the metabolic effects of this carbohydrate load in the pregnant woman and her neonate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fasting
Arm Type
No Intervention
Arm Description
Fasting prior to elective cesarean section delivery (standard of care)
Arm Title
Carbohydrate Drink
Arm Type
Experimental
Arm Description
Subjects will drink 2 carbohydrate drinks prior to elective cesarean section delivery
Intervention Type
Dietary Supplement
Intervention Name(s)
Carbohydrate Drink
Other Intervention Name(s)
Clearfast Preop Drink
Intervention Description
2 - 12 oz drinks
Primary Outcome Measure Information:
Title
Oral glucose tolerance test
Description
glucose, insulin
Time Frame
24 hours postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily E Sharpe, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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