NCT04762251Completed
What Or When to Eat to Reduce the Risk of Type 2 Diabetes (WOW)
Source: ClinicalTrials.gov · Last updated 2 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 247 (actual)
- First submitted
- 16 Feb 2021
- Start date
- Feb 2021
- Primary completion date
- Aug 2023
- Lead sponsor
- University of Adelaide
- Diseases
- Type 2 diabetes
- NCT number
- NCT04762251
What you commit to
- Study type: Interventional
- Participants enrolled: 247
- From Feb 2021 to the primary completion date, Aug 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- 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
- 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:
Other illness
- score on EDEQ ≥2.8 (Eating Disorder Examination Questionnaire)
Lab values
- Type 1 or type 2 diabetes, or diabetes detected at screening HbA1c ≥6.5% (48 mmol/mol).
- 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 \[i.e. 'gliptins'\])
Other
- Beta-blockers
- Glucocorticoids
- 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)
Who the study is looking for
- 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
Age in the registry: 35 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| South Australian Health and Medical Research Institute Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Mary Mackillop Institute for Health Research Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.