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TRE in Type 2 Diabetes (See Food Study 3) (SFS3)

Primary Purpose

Type2Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time restricted eating
Caloric reduction
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2Diabetes focused on measuring Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction, time restricted eating

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Overweight/obese adults with metformin-only treated type 2 diabetes
  • 18-50 years old
  • BMI:25-35 kg/m2
  • HbA1c: 6.5-8.5%
  • duration of diabetes ≤10 years
  • 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.

Sites / Locations

  • University of MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Time restricted eating

Caloric Restriction

Arm Description

daily 8 hour eating window

reduction of caloric intake by 15%

Outcomes

Primary Outcome Measures

Change in glycemic measures- HbA1c (12w)
Change in hemoglobin A1c

Secondary Outcome Measures

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

Full Information

First Posted
March 11, 2022
Last Updated
May 7, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05290246
Brief Title
TRE in Type 2 Diabetes (See Food Study 3)
Acronym
SFS3
Official Title
TRE in Type 2 Diabetes Mellitus (See Food Study 3)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2Diabetes
Keywords
Type 2 diabetes, diet intervention, intermittent fasting, caloric restriction, time restricted eating

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time restricted eating
Arm Type
Experimental
Arm Description
daily 8 hour eating window
Arm Title
Caloric Restriction
Arm Type
Active Comparator
Arm Description
reduction of caloric intake by 15%
Intervention Type
Behavioral
Intervention Name(s)
Time restricted eating
Intervention Description
Limiting daily eating time to an 8 hour window
Intervention Type
Behavioral
Intervention Name(s)
Caloric reduction
Intervention Description
Cut caloric intake by 15%
Primary Outcome Measure Information:
Title
Change in glycemic measures- HbA1c (12w)
Description
Change in hemoglobin A1c
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Weight change (12w)
Description
Change in weight from baseline
Time Frame
12 weeks
Title
Weight change (24w)
Description
Change in weight from baseline
Time Frame
24 weeks
Title
Change in glycemic measures- insulin (12w)
Description
Change in fasting insulin
Time Frame
12 weeks
Title
Change in glycemic measures- insulin (24w)
Description
Change in fasting insulin
Time Frame
24 weeks
Title
Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (24w)
Description
Change in Homeostatic Model Assessment for Insulin Resistance
Time Frame
24 weeks
Title
Change in glycemic measures- Homeostatic Model Assessment for Insulin Resistance (12w)
Description
Change in fasting Homeostatic Model Assessment for Insulin Resistance
Time Frame
12 weeks
Title
Change in glycemic measures- HbA1c (24w)
Description
Change in hemoglobin A1c
Time Frame
24 weeks
Title
Change in glycemic measures- glucose (24w)
Description
Change in continuous glucose monitoring
Time Frame
24 weeks
Title
Change in glycemic measures- glucose (12w)
Description
Change in continuous glucose monitoring
Time Frame
12 weeks
Title
Intervention burden (12w)
Description
Participant self-report via survey
Time Frame
12 weeks
Title
Intervention burden (24w)
Description
Participant self-report via survey
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brad Yentzer or Abdisa Taddese
Phone
612-419-5738
Email
seefoodstudy@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Chow, MD
Organizational Affiliation
University of Minnesota- Division of Endocrinology, Diabetes, and Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brad Yentzer or Abdisa Taddese
Phone
612-419-5738
Email
seefoodstudy@umn.edu

12. IPD Sharing Statement

Learn more about this trial

TRE in Type 2 Diabetes (See Food Study 3)

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