Restricted Eating Time in the Treatment of Type 2 Diabetes

ConditionType 2 Diabetes

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorSteno Diabetes Center Copenhagen

About this trial

The overall aim of the present study is to investigate the effectiveness of implementing a 1-year time-restricted eating (TRE)-based intervention on glycaemic control, body weight and composition, cardiometabolic risk factors, and behaviour in individuals with overweight/obesity and type 2 diabetes (T2D).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: ≥18 years

Overweight or obesity (BMI ≥25 kg/m2)

T2D with HbA1c>53 mmol/mol

Habitual eating window ≥12 h/day (incl. foods/snacks and energy-containing beverages)

Disqualifiers

Bariatric surgery or planned bariatric surgery within study duration

Use of fast acting insulin and combination insulin products

Habitual CGM use

A wish to adhere to Ramadan

Trial design

Design model

Parallel

Treatments tested in this trial

Time restricted eating
Other intervention
3 months (12 weeks) strict TRE intervention: Participants will be instructed to reduce their eating window by minimum 3 hours compared to habitual eating, with an eating window below 10 hours. The timing of the eating window is self-selected but should be placed between 6 am and 8 pm. Diet during the eating window is ad libitum with no further dietary restrictions. 9 months (40 weeks) individually adjusted TRE intervention: An individual plan will be made based on participants' experiences during the strict TRE. Different choices of individual adjustment and support will be provided, including 1) eating window adjustments and the possibility of 'days off', 2) provision of a list of allowed calorie and caffeine free beverages that can be consumed outside the window, 3) continued opportunity to participate in peer-support group meetings, 4) extra phone calls with a project worker to discuss challenges or strategies to continue with TRE etc., and 5) further involvement of relatives.

Treatment groups

160 Participants

are divided into 2 treatment groups

Group A: Time-restricted eatingExperimental treatment 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in HbA1c (mmol/mol)

Assessed from blood samples in fasted state.

Time frame

Change from baseline to 3-months of intervention (strict TRE)

Change in HbA1c (mmol/mol)

Assessed from blood samples in fasted state.

Time frame

Change from baseline to the end of the intervention (12 months)

Secondary outcomes

Body weight (kg)

Measured on a digital scale in a fasted state.

Time frame

Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

Fat mass (kg)

Measured by Dual-energy X-ray Absorptiometry in a fasted state.

Time frame

Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

Time in range (% 3.9-10.0 mmol/l)

Measured using continous glucose monitoring.

Time frame

Change from baseline to end of the intervention (12 months). Measured at baseline, 3 months, 12 months

Use of antidiabetic medication

Change in current use of antidiabetic medication from baseline to end of the intervention (12 months).

Time frame

Change from baseline to end of the intervention (12 months). Assessed at baseline, 3 months, 12 months.

Other outcomes

Body weight (kg)

Measured on a digital scale in a fasted state.

Time frame

Change from baseline to 3 months

Height (m)

Height will be measured in order to calculate BMI.

Time frame

Measured only at screening

Body mass index (kg/m^2)

Weight and height measurements will be used to calculate BMI in kg/m\^2.

Time frame

Change from baseline to 3 months and from baseline to the end of the intervention (12 months). Measured at baseline, 3 months, 12 months

Fat mass (kg)

Measured by Dual-energy X-ray Absorptiometry in a fasted state.

Time frame

Change from baseline to 3 months

Sponsors and contacts

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Steno Diabetes Center Copenhagen

Lead sponsor

University of Leeds

Collaborator

Salk Institute for Biological Studies

Collaborator

University of Copenhagen

Collaborator

Glostrup University Hospital, Copenhagen

Collaborator

Source ClinicalTrials.gov

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