Time-Restricted Feeding on Glucose Homeostasis and Quality of Life
A Pilot Study to Evaluate the Effect of Time-Restricted Feeding on Blood Glucose, Insulin Sensitivity and Quality of Life
1 other identifier
interventional
50
1 country
1
Brief Summary
Background: Time-restricted feeding can improve insulin sensitivity, and increase fat oxidation in people with prediabetes independent of weight loss. It may also help people to lose weight. However, it has not been tested in people with type 2 diabetes. Plan of investigation: Participants meeting the eligibility criteria will be randomized to the TRF arm or the continuous eating arm. Both arms with be given a prescribed dietary plan to help them lose 5% of body weight. In the TRF they will permitted to eat between midday and 6pm. In the continuous eating arm they will be allowed to eat between 8am and 11pm. Participants will attend the nutrition clinic every two weeks to be weighed and be given personalized support to help them follow their assigned diet. Prior to starting the diets outcome measures will be taken: Glycaemia will be measured by a glucose tolerance test, and 7-day continuous glucose monitoring. HbA1c will be taken from fasting blood sample. In addition, the fasting sample will be taken for measurement of insulin, lipid profile and inflammatory markers. We will also use questionnaires to assess quality of life, a 3-day food diary to assess compliance to diet especially meal timings. Capillary ketones will also be used to assess whether compliance to the assigned fasting period. Outcome measures will also be taken during 7 days of the second month, and then the final seven days of the last month on the diet. The primary outcome is HbA1c.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Jul 2019
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 10, 2019
CompletedFirst Submitted
Initial submission to the registry
August 18, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedDecember 13, 2019
December 1, 2019
8 months
August 18, 2019
December 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
Change in HbA1c between the intervention and control arms.
12 weeks
Secondary Outcomes (9)
Body weight
12 weeks
Insulin sensitivity
12 weeks
Diabetes medications
12 weeks
Inflammatory markers
12 weeks
Inflammatory markers
12 weeks
- +4 more secondary outcomes
Study Arms (2)
TRF
EXPERIMENTALEating restricted to between midday and 6pm.
Normal timing of food intake.
PLACEBO COMPARATOREating between 8am and 11pm.
Interventions
Eligibility Criteria
You may qualify if:
- Must agree to follow time restricted feeding protocol if randomized to the TRF arm.
- Age 21-65 years
- T2DM with any diabetes medication
- BMI of 25-45 kg/m2
- Wake up at a regular time between 5-8 am
- Able to provide informed consent.
You may not qualify if:
- Weight loss of more than 5 kg within the past 6 months
- HbA1c of \<6·5% and \>12%
- Serious current or recent illness including cancer or severe or unstable heart failure.
- Participation in another clinical research trial.
- Current treatment with anti-obesity drugs.
- Substance abuse
- Learning difficulties
- Presence of an eating disorder
- Purging behaviour
- Pregnancy or consideration of pregnancy
- Hospital admission for depression or use of antipsychotic drugs.
- Regularly eat within a \<9-hour period each day
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dasman Diabetes Institute
Kuwait City, 15462, Kuwait
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Medical Officer
Study Record Dates
First Submitted
August 18, 2019
First Posted
August 20, 2019
Study Start
July 10, 2019
Primary Completion
March 1, 2020
Study Completion
March 1, 2020
Last Updated
December 13, 2019
Record last verified: 2019-12