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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
Sponsor:
Collaborator:
Duke-NUS Graduate Medical School
Information provided by (Responsible Party):
Singapore General Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in glycaemic control of patients as measured by >= 5% reduction in glycosylated haemoglobin (HbA1C) over a 12 week period. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in Waist Circumference (WC) over a 12 week period. [ Time Frame: 12 weeks ]
    Waist circumference would decrease significantly e.g. 3 centimeters.

  6. 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.

  7. 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.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects (male or female) ≥ 21 to 80 years of age at Visit 1.
  2. Subjects newly diagnosed with Type II diabetes mellitus (DM) who are solely on dietary control.
  3. Ability to sign written informed consent before any study-specific procedure.
  4. Subject is considered reliable and capable of adhering to protocol.
  5. Subjects with Body Mass Index (BMI)≥ 23.5kg/m2.

Exclusion Criteria:

  1. Subjects on Type II diabetes medication.
  2. Subjects with any of the following medical conditions:

    • Congestive cardiac failure.
    • Stage 4 or worse chronic kidney disease (i.e. eGFR < 30 ml/min/1.73 m2)
    • Child's B or worse liver cirrhosis.
    • Any medical condition that in the opinion of the investigator could jeopardize or compromise the subject's ability to participate in the study.
  3. Subject with previous or present history of eating disorder.
  4. Subject not able to understand the informed consent form or fasting diary instructions.
  5. Subject has participated in another study of an investigational medication or an investigational medical device within the last 30 days or is currently participating in these studies.
  6. Subject is pregnant or lactating.

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): NCT03940482


Contacts
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Contact: Nur Syahirah Alias +65 63265065 nur.syahirah.alias@sgh.com.sg
Contact: Lee Kheng Hock +65 6222 3322 lee.kheng.hock@singhealth.com.sg

Locations
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Singapore
Singapore General Hospital (Clinical Trials and Research Centre) Recruiting
Singapore, Singapore, 169608
Contact: Syahirah Alias    63265065    nur.syahirah.alias@sgh.com.sg   
Contact: Lee Kheng Hock    6222 3322    lee.kheng.hock@singhealth.com.sg   
Principal Investigator: Lee Kheng Hock, A/Prof         
Sub-Investigator: Gabriel Yee, Dr         
Sponsors and Collaborators
Singapore General Hospital
Duke-NUS Graduate Medical School
Investigators
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Principal Investigator: Lee Kheng Hock Singapore General Hospital
Publications:

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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03940482    
Other Study ID Numbers: TREAT-DM-01
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021

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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 Singapore General Hospital:
TYPE 2 Diabetes Mellitus
Intermittent Fasting
Time Restricted Eating as Treatment (TREAT)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases