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Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT05015504
Recruitment Status : Not yet recruiting
First Posted : August 20, 2021
Last Update Posted : October 5, 2021
Sponsor:
Collaborator:
Ohio University
Information provided by (Responsible Party):
OhioHealth

Brief Summary:
In this 3-week interventional study, the investigators hypothesize that therapeutic Time-Restricted Feeding in patients with poorly controlled Type 2 diabetes mellitus (T2DM) can improve their mean glucose or estimated glycated hemoglobin levels with the same dose, or even reduced dose, of antidiabetics.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Time restricted feeding Not Applicable

Detailed Description:
Time-restricted feeding (TRF) has recently gained popularity as a means of reducing body weight and improving glycemia. A recent clinical trial in men who had prediabetes showed that TRF for five weeks significantly reduced fasting insulin concentration and improved the derived oral glucose tolerance test ( OGTT) indexes of beta-cell responsiveness and insulin resistance. However, the effects of TRF have not been studied in patients with poorly controlled Type 2 diabetes mellitus (T2DM). In this 3-week interventional self-controlled clinical trial, the investigators hypothesize that TRF in patients with poorly-controlled T2DM can improve their mean glucose with the same dose/reduced dose of antidiabetics. Potential study subjects will be identified from Endocrinology clinic patients with a diagnosis of poorly controlled type 2 DM (A1c >= 8.0 in the 3 months before enrollment) based on inclusion and exclusion criteria. All study subjects will be in the ad libitum feeding phase for one week, and then will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for the second week. For the third and final week, patients will be returned to the ad libitum feeding phase. The first and third weeks will serve as the control phases, and the second week will be the experimental phase. The mean glucose, serum triglyceride levels, insulin resistance, and body weights will be compared between the two phases. Results of this clinical study may demonstrate a low-cost and practical way of diabetic control.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group self comparison
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Time restricted feeding
The study will consist of three phases. In phase I all study subjects will be in the ad libitum feeding phase for one week followed by Phase II. In Phase II the subjects will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for one week. For phase III (final week), patients will be returned to an ad libitum feeding. The first and third phases will serve as control phases, and the second phase will be the experimental phase
Behavioral: Time restricted feeding
In Phase II the study subjects will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for one week.
Other Name: Ad libitum feeding




Primary Outcome Measures :
  1. mean glucose [ Time Frame: in one week of time restricted feeding ]
    change in mean glucose

  2. estimated hemoglobin A1c levels [ Time Frame: in one week of time restricted feeding ]
    change in estimated hemoglobin A1c levels


Secondary Outcome Measures :
  1. Insulin resistance [ Time Frame: in one week of time restricted feeding ]
    change in Insulin resistance is represented by the homeostatic model of assessment of insulin resistance

  2. serum triglyceride levels [ Time Frame: in one week of time restricted feeding ]
    change serum triglycerides are measured by a fasting lipid panel

  3. body weight [ Time Frame: in one week of time restricted feeding ]
    change in body weight



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years and < 65 years
  • With the diagnosis of type 2 diabetes
  • A1c >= 8.0 on the most recent test in the 3 months before enrollment
  • Have been on stable antidiabetics in the 3 months before enrollment
  • OhioHealth Patient

Exclusion Criteria:

  • Pregnant or breastfeeding patients
  • Severe hypoglycemic episodes (defined as having low blood glucose levels that requires assistance from another person to treat) in the past 12 months
  • Unable to give informed consent
  • Currently enrolled in another therapeutic study
  • Thyroid dysfunction, as defined by abnormal thyroid function test results within the past 6 months
  • Advanced stage of renal (stage 4 or above) or hepatic (cirrhosis) or respiratory (needs oxygen) or heart failure (NYHA class 3 or above)
  • Active infection or malignancy
  • Dementia, or other significant mental impairment that would, in the opinion of the investigator, impede patient self-reporting
  • Clinician-reported history of patient non-adherence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05015504


Contacts
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Contact: Yuanjie Mao, MD, PhD 740-566-4880 yuanjie.mao@ohiohealth.com
Contact: Marie M Lockhart, PhD 614-566-1254 Marie.Lockhart@ohiohealth.com

Sponsors and Collaborators
OhioHealth
Ohio University
Investigators
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Principal Investigator: Yuanjie Mao, MD, PhD OhioHealth
Publications:
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Responsible Party: OhioHealth
ClinicalTrials.gov Identifier: NCT05015504    
Other Study ID Numbers: 1770741-4
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by OhioHealth:
intermittent fasting
type 2 diabetes
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases