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Clinical Trials/NCT03592784
NCT03592784
Terminated
Not Applicable

Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus

Weill Medical College of Cornell University1 site in 1 country28 target enrollmentJune 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes
Sponsor
Weill Medical College of Cornell University
Enrollment
28
Locations
1
Primary Endpoint
Feasibility of the Food Order Intervention
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

This is a randomized controlled feasibility trial for women diagnosed with gestational diabetes mellitus (GDM). The current front-line treatment for GDM is medical nutrition therapy (MNT), i.e. personalized diets which may or may not include mild carbohydrate restriction. Use of carbohydrate restriction increases the risk of the mother developing ketosis, a harmful condition for both the mother and fetus. If MNT is not enough to stabilize blood sugar levels, then pharmaceuticals are prescribed. In patients with type-2 diabetes and prediabetes, the carbohydrate-last food order behavior has been shown to improve post-meal blood sugar control without the need of reduced carbohydrate intake. Given this data, the addition of this intervention to MNT in patients with GDM may be helpful in achieving controlled blood sugar levels without increasing the risk of ketosis. This study will include two randomized groups diagnosed with GDM. Patients in the control group will be prescribed standard MNT. Patients in the intervention group will have identical MNT but with additional food order instruction/therapy. All patients will be followed up with at 1-2 week intervals. At each follow-up the physician and dietician will analyze the patient's blood sugar measurements and, among additional factors, determine if pharmaceuticals should be added. Treatment will continue through delivery. The primary aim of this study is to assess the feasibility of the carbohydrate last food order in GDM and generate preliminary data on its effects on glucose control.

Registry
clinicaltrials.gov
Start Date
June 18, 2018
End Date
April 22, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Pregnant subjects ≥18 years old
  • Newly diagnosed with GDM between 24-32 weeks of gestation with at least 2 days of self-monitored glucose logs or diagnosed via a 50g glucose challenge test (GCT) greater than 200mg/dL

Exclusion Criteria

  • Pre-existing diabetes prior to conception
  • Patients whom do not plan on consuming at least 3 meals daily throughout gestation (e.g. during Ramadan)
  • Requirement of special medical diet (e.g. from phenylketonuria, celiac disease, etc.)
  • History of bariatric surgery

Outcomes

Primary Outcomes

Feasibility of the Food Order Intervention

Time Frame: 8 weeks

Measured via feasibility questionnaire.

Secondary Outcomes

  • Average 1-hour postprandial glucose(2, 4, 6, 8, 10, 12 weeks)
  • Time to initiation of pharmacotherapy(2, 4, 6, 8, 10, 12 weeks)
  • Proportion of patients requiring the addition of pharmacotherapy(Week 16 or End of study (at delivery))
  • Birthweight(Week 16 or End of study (delivery))

Study Sites (1)

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