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 (TREAT)
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|ClinicalTrials.gov Identifier: NCT03940482|
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : March 11, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Behavioral: Time Restricted Eating As Treatment (TREAT) for Diabetes.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||January 14, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: Single Arm
Subjects will act as their own controls
Behavioral: Time Restricted Eating As Treatment (TREAT) for Diabetes.
Participants will skip a meal every day and maintain a water only fast for 16 hours. A fasting diary is kept to track hours of fasting. Participants will follow this new pattern of eating for 12 weeks. They will visit the doctor's office at least 3 times in the course of the study and will be followed up with anthropometry (weight, BMI and waist circumference) and biochemical markers pertaining to Diabetes during the study visits. At 24 weeks, a follow up phone call will be made to check self-reported compliance to intermittent fasting.
- Change in glycaemic control of patients as measured by >= 5% reduction in glycosylated haemoglobin (HbA1C) over a 12 week period. [ Time Frame: 12 weeks ]
- Change in glycaemic control of patients as measured by fasting glucose and 2 hour post prandial glucose over a 12 week period. [ Time Frame: 12 weeks ]Fasting glucose would reduce significantly e.g. 0.5 mmol/L over a 12 week period. Post prandial glucose would decrease significantly e.g. 0.5 mmol/L over a 12 week period.
- Change in Blood Pressure (BP) over a 12 week period. [ Time Frame: 12 weeks ]Blood pressure would decrease significantly e.g. a systolic blood pressure drop of 7 mm Hg.
- Change in Weight over a 12 week period. [ Time Frame: 12 weeks ]Weight would reduce significantly e.g. 5% of initial body weight in kilograms.
- Change in Body Mass Index (BMI) over a 12 week period. [ Time Frame: 12 weeks ]Body Mass Index would decrease significantly e.g. 1 kg/m^2.
- Change in Waist Circumference (WC) over a 12 week period. [ Time Frame: 12 weeks ]Waist circumference would decrease significantly e.g. 3 centimeters.
- Change in the lipid profiles of patients, namely Total Cholesterol (TC), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Triglycerides (TG), over a 12 week period. [ Time Frame: 12 weeks ]Low density Lipoprotein would decrease significantly e.g. 0.5 mmol/L. Triglyceride experience a significant reduction e.g. 0.5 mmol/L.
- Change in a levels of ketonemia (Serum Beta-Hydroxybutyrate 0.5-3.0 mmol/L) over a 12 week period. [ Time Frame: 12 weeks ]Presence or absence of ketonemia evidenced by Serum Beta-Hydroxybutyrate 0.5-3.0 mmol/L over a 12 week period.
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): NCT03940482
|Contact: Nur Syahirah Alias||+65 firstname.lastname@example.org|
|Contact: Lee Kheng Hock||+65 6222 email@example.com|
|Singapore General Hospital (Clinical Trials and Research Centre)||Recruiting|
|Singapore, Singapore, 169608|
|Contact: Syahirah Alias 63265065 firstname.lastname@example.org|
|Contact: Lee Kheng Hock 6222 3322 email@example.com|
|Principal Investigator: Lee Kheng Hock, A/Prof|
|Sub-Investigator: Gabriel Yee, Dr|
|Principal Investigator:||Lee Kheng Hock||Singapore General Hospital|