Food Order Intervention for Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03592784
• Other study ID #: 1802018956
• Status: Terminated
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: April 22, 2020

Study information

• Verified date: November 2020
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: April 22, 2020
• Est. primary completion date: March 19, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Behavioral:
• Food Order Therapy
Instructing patient to, whenever possible, eat carbohydrates at the end of their meal.
• Medical Nutrition Therapy
Key components of this therapy include counseling to incorporate portion control, increased intake of vegetables and low glycemic index carbohydrates, and mild carbohydrate restriction.

Locations

Country	Name	City	State
United States	Materal-Fetal Medicine of Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the Food Order Intervention	Measured via feasibility questionnaire.	8 weeks
Secondary	Average 1-hour postprandial glucose	Averaged from self-monitored blood glucose logs.	2, 4, 6, 8, 10, 12 weeks
Secondary	Time to initiation of pharmacotherapy	Measured in weeks from enrollment in the study.	2, 4, 6, 8, 10, 12 weeks
Secondary	Proportion of patients requiring the addition of pharmacotherapy	Measured as a percentage of patients in each arm.	Week 16 or End of study (at delivery)
Secondary	Birthweight	Measured in lbs.	Week 16 or End of study (delivery)