Project Details
Description
ABSTRACT
With the support of PAS-20-160 “Small R01s for Clinical Trials Targeting Diseases within the Mission of
NIDDK,” we will perform a feasibility study to test our overall hypothesis that TRE presents a viable
alternative to caloric restriction for improving glycemic measures and reducing weight in
overweight/obese patients [BMI:25-35 kg/m2] with metformin-only treated Type 2 diabetes (T2DM). The
rationale for this study arises from the observation that intentional caloric restriction plays an integral part in
glycemic management in patients with newly diagnosed/early-stage T2DM. Yet intentional caloric restriction is
difficult to sustain due to multiple barriers, including challenges arising from acquiring the necessary
knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to
intentionally restricting calories, time restricted eating (TRE), focuses on restricting the eating window. This
simplified view of eating allows participants to eat ad libitum per their dietary preferences during a daily time
frame. TRE is associated with weight loss in patients without T2DM and improves glycemic measures in
patients with prediabetes, however its effects on glycemic measures, especially when accounting for weight
change, in patients with T2DM remains unknown.
This study will involve a 24-week intervention of TRE vs Caloric Restriction (n=56 total, n=28 per group)
which will be staff supervised for 12 weeks and self-maintained for 12 weeks. We will use innovative state of
the art technology such as Zoom-based virtual visits, mobile phone-based food record, wifi-enabled scale for
weekly weights, continuous glucose monitoring and actigraphy to implement our interventions and assess
outcomes. Our Specific Aims include: Aim #1: Compare the effect of TRE vs Caloric Restriction on glycemic
measures, Aim#2: Compare the effect of TRE vs Caloric Restriction on weight, Aim #3: Compare the effect of
TRE vs Caloric Restriction on intervention burden. The impact and significance of this feasibility study is to
provide preliminary data to support a definitive randomized controlled trial of TRE to treat hyperglycemia in
patients with T2DM.
Status | Finished |
---|---|
Effective start/end date | 4/1/22 → 3/31/24 |
Funding
- National Institute of Diabetes and Digestive and Kidney Diseases: $332,500.00
- National Institute of Diabetes and Digestive and Kidney Diseases: $310,000.00
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