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NCT03592784 · ClinicalTrials.gov registry record · NA
Food Order Intervention for Gestational Diabetes
A NA study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03592784 is a NA study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 28 participants.
The verdict
NCT03592784, a NA study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Medical Nutrition Therapy
- BEHAVIORAL Food Order Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-06-18 |
| Est. Completion | 2020-04-22 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03592784
The ClinicalTrials.gov registry entry for NCT03592784 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Medical Nutrition Therapy is the first listed.
NCT03592784 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03592784 about?
NCT03592784 is a clinical study titled "Food Order Intervention for Gestational Diabetes". 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 restric...
What is the current status of trial NCT03592784?
This trial is currently terminated. It is a NA study. The enrollment target is 28 participants. The study started on 2018-06-18. Estimated completion is 2020-04-22.
What interventions are being tested in trial NCT03592784?
The interventions under investigation include: Medical Nutrition Therapy (BEHAVIORAL), Food Order Therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03592784?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
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