Ignite Creation Date:
2024-05-06 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03592784
Status:
TERMINATED
Last Update Posted:
2020-11-23
First Post:
2018-06-18
Brief Title:
Food Order Intervention for Gestational Diabetes
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Carbohydrate-Last Food Order Intervention for Gestational Diabetes Mellitus
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment during Covid pandemic however sufficient data gathered for assessment of primary outcome
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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 instructiontherapy All patients will be followed up with at 1-2 week intervals At each follow-up the physician and dietician will analyze the patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None