What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)

Not Applicable

Completed

• Conditions: Time-restricted Eating; Diet Quality

• Registration Number: NCT04762251
• Lead Sponsor: University of Adelaide

Brief Summary

A parallel, single-blinded, multi-centre randomized controlled trial conducted at the South Australian Health and Medical Research Institute (SAHMRI) and the Mary Mackillop Institute for Health Research (MMIHR; Australian Catholic University), by researchers from the University of Adelaide, Australian Catholic University and La Trobe University.

Detailed Description

In a parallel groups design, a total of 268 individuals will be recruited across both sites. After a 2-week baseline period, and a baseline metabolic visit, participants will be randomized into one of two groups (TRE, time-restricted eating; CP, current practice guidelines). All participants will receive five (5) telehealth consultations at baseline, week 2, 4, 8 and 12, the content of which will be based around their randomized condition. They will undergo metabolic testing on two (2) further occasions (4 months, 12 months) over a 12-month period to assess the changes in primary and secondary outcomes.

Study Timeline

• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Study Start: 2021-02-17
• Study First Posted: 2021-02-21
• Primary Completion: 2023-08-02
• Study Completion: 2024-04-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

Inclusion Criteria

• Study participants will be aged 35 to 70 years, overweight or obese (BMI: >25 but <45 kg/m2), ≥15 on the AUSDRISK assessment tool and have HbA1c <6.5% at screening

Exclusion Criteria

Type 1 or type 2 diabetes, or diabetes detected at screening HbA1c ≥6.5% (48 mmol/mol).

• A personal history/diagnosis (self-reported) of:

  • major psychiatric disorders (schizophrenia, major depressive disorder, bipolar disorder, eating disorders)
  • gastrointestinal disorders/disease (including malabsorption)
  • haematological disorders (i.e. thalassemia, iron-deficiency anaemia)
  • insomnia
  • currently receiving, or have received treatment/diagnosis of cancer in the past 3 years (excluding non-melanoma skin cancer)
  • significant liver or kidney disease
  • previous or planned gastro-intestinal surgery (including bariatric surgery)
  • Congestive heart failure (NYHA stage 2 or above)
  • Previous myocardial infarction or significant cardiac event ≤ 6 months prior to screening
  • Previous cerebrovascular event ≤ 12 months prior to screening

and/or any other condition deemed unstable by the study physician.

Currently taking the following medications:

• any medication used, or known to lower blood glucose, or antidiabetic medications, including, but not limited to: SGLT2 inhibitors, metformin, sulfonylureas, glucagon-like peptide-1 (GLP-1) analogues [i.e. exenatide], thiazolidinediones or DPP-IV inhibitors [i.e. 'gliptins'])
• Medications affecting weight, appetite or gut motility, including, but not limited to: (domperidone, cisapride, orlistat, phentermine, topiramate).
• Diuretics (i.e. frusemide, thiazides) or combination blood pressure medications containing a diuretic
• Beta-blockers
• Glucocorticoids
• Anti-epileptic medications
• Antipsychotic medications
• Opioid medications unless combined with paracetamol in a single formulation and used occasionally on a PRN basis

Additional exclusion criteria include:

• do not consume a regular breakfast (i.e. eat breakfast on an average of 5 or more days per week), and do not eat for more than 12 hours per day on an average of 5 or more days per week
• have an extreme or restricted pattern of eating (i.e. following an intermittent fasting diet) or are already engaged in a TRE protocol
• shift-workers
• pregnant, planning a pregnancy or currently breastfeeding
• those who have lost or gained >5% of body weight in the last 6 months
• current smokers of cigarettes/marijuana/e-cigarettes/vaporisers
• anyone unable to comprehend the study protocol or provide informed consent (i.e. due to English language or cognitive difficulties)
• Participants will not have seen a dietitian in the preceding 3 months.
• score on K10 ≥30 (Kessler Psychological Distress scale)
• score on EDEQ ≥2.8 (Eating Disorder Examination Questionnaire)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	baseline, 4 months	Glycated haemoglobin concentration

Secondary Outcome Measures

Name	Time	Method
HOMA-IR	baseline, 4 months, 12 months	HOMA-IR
Fasting blood glucose	baseline, 4 months, 12 months	fasting blood glucose concentrations
Nocturnal glucose	baseline, 4 months	AUC of glucose assessed by CGM from midnight to 0400
HbA1c	12 months	Glycated haemoglobin concentration
Fasting insulin	baseline, 4 months, 12 months	fasting insulin concentrations

Trial Locations

Locations (2)

South Australian Health and Medical Research Institute; 🇦🇺 Adelaide, South Australia, Australia

Mary Mackillop Institute for Health Research; 🇦🇺 Melbourne, Victoria, Australia