Type 2 Diabetes Clinical Trial
Official title:
Application of Time Restriction Feeding in Patients With Type 2 Diabetes Mellitus
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 2025 |
Est. primary completion date | July 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | OhioHealth Castrop Health Center | Athens | Ohio |
Lead Sponsor | Collaborator |
---|---|
OhioHealth | Ohio University |
United States,
Barnosky AR, Hoddy KK, Unterman TG, Varady KA. Intermittent fasting vs daily calorie restriction for type 2 diabetes prevention: a review of human findings. Transl Res. 2014 Oct;164(4):302-11. doi: 10.1016/j.trsl.2014.05.013. Epub 2014 Jun 12. — View Citation
Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10. — View Citation
Zubrzycki A, Cierpka-Kmiec K, Kmiec Z, Wronska A. The role of low-calorie diets and intermittent fasting in the treatment of obesity and type-2 diabetes. J Physiol Pharmacol. 2018 Oct;69(5). doi: 10.26402/jpp.2018.5.02. Epub 2019 Jan 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mean glucose | change in mean glucose | in one week of time restricted feeding | |
Primary | estimated hemoglobin A1c levels | change in estimated hemoglobin A1c levels | in one week of time restricted feeding | |
Secondary | Insulin resistance | change in Insulin resistance is represented by the homeostatic model of assessment of insulin resistance | in one week of time restricted feeding | |
Secondary | serum triglyceride levels | change serum triglycerides are measured by a fasting lipid panel | in one week of time restricted feeding | |
Secondary | body weight | change in body weight | in one week of time restricted feeding |
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