Time-restricted eating in individuals with type 2 diabetes

Not Applicable

Completed

• Conditions: Type 2 diabetes; Diet and Nutrition - Other diet and nutrition disorders; Overweight/obesity; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12618000938202
• Lead Sponsor: Dr Evelyn Parr

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-04
• Study Completion: 2019-11-18
• Last Update Posted: 3 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•Aged 35 to 65 years old
•Diagnosed (by a GP/endocrinologist) with type 2 diabetes mellitus (T2D), with an HbA1c between 6.5% - 9%, either with diet-controlled or taking up to two oral hypoglycaemic agents (excluding sulphonylureas)
•Body mass index (BMI) between 25 - 45 kg/m2 (but total mass not >200 kg due to DXA measures)
•Currently consuming energy (i.e. dietary intake) over a period of 12 h or more, habitually (i.e. self-reported on 5/7 days per week)

Exclusion Criteria

•Not a regular breakfast consumer;
•Does not have a smart phone or cannot operate the camera function on a smart phone;
•Taking more than 2 oral hypoglycaemic agents (OHAs), taking sulphonylrueas, or other glucose lowering medications (i.e. GLP-1 angonists, or insulin), or unstable use of OHA (i.e. not taking them for at least a 3 month period).
•Currently following a strict diet (i.e. vegan, coeliac/gluten free, ketogenic);
•Participate in regular fasting (defined as fasting for greater than or equal to 16 h/day or having completed twelve 24-h fasts within the past year);
•Participating in shift work (i.e. >3 h between 10 pm and 5 am for 1 day per week (>50 days per year))
•Not weight stable (>5 kg change over last 3 months);
•On prescribed medications required to be taken with food in the early morning or late evening or taking other prescribed medications for <3 months;
•Current smoker (tobacco, nicotine or marijuana) or within 3 months of quitting;
•Women who are pregnant, breastfeeding (within 24 wk);
•History of psychotic disorder, current diagnosis of other major psychiatric illness (e.g. mood disorder, eating disorder, substance use disorder; does not include depression)
•Psychopharmacological treatment that has not been stable for more than 3 months;
•Medications known to promote weight gain, weight loss or interact with glucose metabolism (i.e. corticosteroids);
•Diagnosed gastrointestinal conditions, surgery (i.e. bariatric) or impaired nutrient absorption;
•Antibiotic use in previous 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified