TRE in Type 2 Diabetes (See Food Study 3)

Study Overview
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Brief Summary
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Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including 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), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients [BMI:25-35 kg/m2] with metformin-only treated Type 2 diabetes.

Official Title
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TRE in Type 2 Diabetes Mellitus (See Food Study 3)

Conditions
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Type2Diabetes

Intervention / Treatment
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* Behavioral: Time restricted eating
* Behavioral: Caloric reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Overweight/obese adults with metformin-only treated type 2 diabetes 18-65 years old BMI:25-40 kg/m2 HbA1c: 6.5-8.5% Self-reported weight must be stable [±5 pounds] for at least 3 months prior to the study Owns a smartphone. Exclusion Criteria: Active or anticipated pregnancy during the study type 2 diabetes treated with medications other than metformin presence of eating disorders as noted by screening survey.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time restricted eating<br>daily 8 hour eating window | Behavioral: Time restricted eating<br>* Limiting daily eating time to an 8 hour window<br>|
| Active Comparator: Caloric Restriction<br>reduction of caloric intake by 15% | Behavioral: Caloric reduction<br>* Cut caloric intake by 15%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycemic measures- HbA1c (12w) | Change in hemoglobin A1c | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change (12w) | Change in weight from baseline | 12 weeks | 
| Weight change (24w) | Change in weight from baseline | 24 weeks | 
| Change in glycemic measures- insulin (12w) | Change in fasting insulin | 12 weeks | 
| Change in glycemic measures- insulin (24w) | Change in fasting insulin | 24 weeks | 
| Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (24w) | Change in Homeostatic Model Assessment for Insulin Resistance | 24 weeks | 
| Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (12w) | Change in fasting Homeostatic Model Assessment for Insulin Resistance | 12 weeks | 
| Change in glycemic measures- HbA1c (24w) | Change in hemoglobin A1c | 24 weeks | 
| Change in glycemic measures- glucose (24w) | Change in continuous glucose monitoring | 24 weeks | 
| Change in glycemic measures- glucose (12w) | Change in continuous glucose monitoring | 12 weeks | 
| Intervention burden (12w) | Participant self-report via survey | 12 weeks | 
| Intervention burden (24w) | Participant self-report via survey | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction, time restricted eating