NCT03592784

Food Order Intervention for Gestational Diabetes

Terminated NA Last updated 23 November 2020

What this trial tests

NA trial testing Food Order Therapy in Gestational Diabetes in 28 participants. Terminated before completion.

Timeline

18 June 2018

Primary endpoint
19 March 2020

22 April 2020

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	18 June 2018
Primary completion	19 March 2020
Estimated completion	22 April 2020
Sites	1 location across United States

Drugs / interventions tested

• Food Order Therapy
• Medical Nutrition Therapy

Conditions studied

• Gestational Diabetes — all drugs for Gestational Diabetes →

Sponsor

Weill Medical College of Cornell University

Who can join

18 and older, female only, with Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.