NCT03940482: TREAT

Time Restricted Eating As Treatment (TREAT) for Diabetes Mellitus: A Pre-Post 12 Week Study on the Effectiveness of Intermittent Fasting in Asians With Type 2 Diabetes Mellitus

Status unknown NA Last updated 7 September 2023

What this trial tests

NA trial testing Time Restricted Eating As Treatment (TREAT) for Diabetes. in Type 2 Diabetes Mellitus in 50 participants. Status unknown.

Timeline

14 January 2019

Primary endpoint
31 August 2023

30 December 2023

Quick facts

Lead sponsor	Singapore General Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	14 January 2019
Primary completion	31 August 2023
Estimated completion	30 December 2023
Sites	1 location across Singapore

Drugs / interventions tested

• Time Restricted Eating As Treatment (TREAT) for Diabetes.

Conditions studied

• Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Singapore General Hospital

Who can join

Adults 21 to 80, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Type 2 Diabetes Mellitus (DM) is a silent epidemic that affects 11.3% of Singaporeans. It has numerous clinical sequelae including macrovascular and microvascular disease. Nutritional therapy has been widely accepted as being safe and affordable as compared to pharmacotherapy. It is estimated that current nutritional therapy is able to reduce HbA1c levels by 1 to 2 percent under ideal circumstances. A weight loss of \>5% is needed to have any significant beneficial effects on the levels of HbA1c, lipids, and blood pressure. This requires extensive modification of lifestyle, calorie restriction, regular exercise, and close supervision by health care professionals; impracticable for most patients. Intermittent Fasting that has been shown to be effective in improving the metabolic state of human subjects. The investigators ask if a simpler dietary regime based on time restricted eating would produce the necessary weight loss and good metabolic outcome.

In this pilot single arm pre-post study, 50 adult diabetic patients will be educated on Time Restricted Eating As Treatment (TREAT). Under this intervention, subjects will skip one meal a day and aim for a fasting period 16 hours a day. In the 8 hours where eating is permitted, subjects are encouraged to eat normally based on what is recommended for diabetic patients in usual care. Relevant clinical parameters, such as blood glucose control, lipid and triglyceride levels and anthropometry will be monitored over a 12-week period.

This study would have major clinical impact if it is found that TREAT can result in the improvement of cardiometabolic parameters and is practicable and sustainable in a real world setting.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Time-restricted eating: Watching the clock to treat obesity.
   Ezpeleta M, Cienfuegos S, Lin S, Pavlou V, et al · · 2024 · cited 83× · PMID 38176412 · DOI 10.1016/j.cmet.2023.12.004