Clinical trial NCT03592784: Food Order Intervention for Gestational Diabetes
Official title: Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Feasibility of the Food Order Intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: Average 1-hour postprandial glucose
timeFrame: 2, 4, 6, 8, 10, 12 weeks
measure: Time to initiation of pharmacotherapy
timeFrame: 2, 4, 6, 8, 10, 12 weeks
measure: Proportion of patients requiring the addition of pharmacotherapy
timeFrame: Week 16 or End of study (at delivery)
measure: Birthweight
timeFrame: Week 16 or End of study (delivery)
Other outcomes:
Locations:
city: New York
country: United States
facility: Materal-Fetal Medicine of Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Alpana P Shukla, MD
role: PRINCIPAL_INVESTIGATOR
References: