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

NCT03940482 | Unknown

• 1 other identifier: TREAT-DM-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

TYPE 2 Diabetes Mellitus; Intermittent Fasting; Time Restricted Eating as Treatment (TREAT)

Outcome Measures

Primary Outcomes (1)

• Change in glycaemic control of patients as measured by >= 5% reduction in glycosylated haemoglobin (HbA1C) over a 12 week period.

  12 weeks

Secondary Outcomes (7)

• Change in glycaemic control of patients as measured by fasting glucose and 2 hour post prandial glucose over a 12 week period.

  12 weeks

• Change in Blood Pressure (BP) over a 12 week period.

  12 weeks

• Change in Weight over a 12 week period.

  12 weeks

• Change in Body Mass Index (BMI) over a 12 week period.

  12 weeks

• Change in Waist Circumference (WC) over a 12 week period.

  12 weeks

Study Arms (1)

Single Arm

EXPERIMENTAL

Subjects will act as their own controls

Behavioral: Time Restricted Eating As Treatment (TREAT) for Diabetes.

Interventions

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

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.

Single Arm

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects on Type II diabetes medication.
• 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.
• Subject with previous or present history of eating disorder.
• Subject not able to understand the informed consent form or fasting diary instructions.
• 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.
• Subject is pregnant or lactating.

Sponsors & Collaborators

• Singapore General Hospital: lead
• Duke-NUS Graduate Medical School: collaborator

Study Sites (1)

Singapore General Hospital (Clinical Trials and Research Centre)

Singapore, 169608, Singapore

Location

Related Publications (19)

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  PMID: 15640462 BACKGROUND

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  PMID: 28106818 BACKGROUND

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  PMID: 22889512 BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Lee Kheng Hock

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: May 7, 2019
• Study Start: January 14, 2019
• Primary Completion: August 31, 2023
• Study Completion: December 30, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

SG (1)