Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152588
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-10-27
Brief Title:
Restricted Eating Time in the Treatment of Type 2 Diabetes
Sponsor:
Steno Diabetes Center Copenhagen
Organization:
Steno Diabetes Center Copenhagen
Study Overview
Official Title:
Restricted Eating Time in the Treatment of Type 2 Diabetes - the RESET2 Trial
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESET2
Brief Summary:
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 overweightobesity and type 2 diabetes T2D
Detailed Description:
In people with type 2 diabetes T2D weight loss is associated with improved glycaemic control and markers of cardiometabolic function as well as reduced use of antidiabetic medicine Beyond pharmacological treatments current strategies to reduce body weight and improve glycaemia include energy-restricted diets and increased physical activity
Lifestyle interventions are complex affecting many aspects of peoples daily life Dietary restrictions often result in rapid weight loss but the weight is gradually regained by many Barriers to implement and maintain dietary changes include relapse of old habits and lack of knowledge support and insights into the type and amount of foods eaten Previous lifestyle interventions targeting weight loss in T2D show efficacy for improving markers of metabolic and cardiovascular risk including body weight and glycaemia during the intervention but weight regain is often present One reason may be that the intervention is not modified according to the needs of the target group Often weight loss interventions are shaped by a one size fits all approach where both individual capabilities and motivation as well as social and contextual factors are more or less ignored A user-based design could facilitate enrolment of participants and promote implementation and maintenance of the intervention among participants
Intermittent fasting regimens have been suggested as efficient strategies for improving cardiometabolic health to a greater extent than can be attributed to the reduction in energy intake alone TRE limits the time available for food intake to typically 8-10 hoursday without other dietary restrictions and has been put forward as a novel acceptable and safe strategy that has shown promising effects on body weight glucose metabolism appetite and cardiometabolic health in individuals at high risk of T2D
Although it has been suggested that TRE is a safe and feasible intervention the longer-term effectiveness of TRE on glycaemic control and weight loss in individuals with T2D is unknown alongside the long-term acceptability and sustainability Additionally potential social and contextual challenges associated with integration of TRE into ordinary daily life structure and routines call for new approaches to support the individual in implementing and maintaining the strategy
Overall the RESET2 study consists of three phases 1 Need assessment 2 Pilot study and 3 RCT The aim of the present study RCT is to investigate the effectiveness of implementing a 1-year TRE-based intervention in individuals with overweightobesity and T2D Participants will attend 6 visits at Steno Diabetes Center Copenhagen SDCC Visit 0 screening Visit 1 baseline minimum 10 days after screening Visit 2 10 days prior to visit 3 Visit 3 3 months 12 weeks after baseline Visit 4 10 days prior to visit 5 Visit 5 12 months 52 weeks after baseline
The specific objectives are
1 To investigate the effect of a 1-year TRE intervention on changes in glycaemic control HbA1c in individuals with overweightobesity and T2D
2 To investigate the effects of a 1-year TRE intervention on changes in body weight fat mass continuous glucose monitoring CGM recorded time in range TIR 39-100 mmoll and use of antidiabetic medication in individuals with overweightobesity and T2D
3 To describe changes in cardiometabolic risk factors including fat-free mass blood lipids markers of kidney and liver function and inflammation hormones involved in glucose metabolism and appetite control liver fat blood pressure waist- and hip circumference time below range TBR time above range TAB cognition food preferences and reward dim light melatonin onset DLMO and patient-reported outcomes including self-rated health physical activity well-being diabetes distress depression food intake and sleep quality
4 To investigate the effects of a 3-month TRE intervention on changes in brain insulin sensitivity sub-study
5 To describe the extent to which the intervention was conducted as planned visits conversations phone calls peer support activities
6 To describe the extent to which participants participated in support-related activities
7 To explore participants experiences with following TRE throughout a year including how they managed to keep their eating window and how the supporting activities and individualized approach worked for them sub-population
8 To explore the results from objectives 1-7 in relation to the extent the participants adhered to eating windows
Lifestyle interventions are complex affecting many aspects of peoples daily life Dietary restrictions often result in rapid weight loss but the weight is gradually regained by many Barriers to implement and maintain dietary changes include relapse of old habits and lack of knowledge support and insights into the type and amount of foods eaten Previous lifestyle interventions targeting weight loss in T2D show efficacy for improving markers of metabolic and cardiovascular risk including body weight and glycaemia during the intervention but weight regain is often present One reason may be that the intervention is not modified according to the needs of the target group Often weight loss interventions are shaped by a one size fits all approach where both individual capabilities and motivation as well as social and contextual factors are more or less ignored A user-based design could facilitate enrolment of participants and promote implementation and maintenance of the intervention among participants
Intermittent fasting regimens have been suggested as efficient strategies for improving cardiometabolic health to a greater extent than can be attributed to the reduction in energy intake alone TRE limits the time available for food intake to typically 8-10 hoursday without other dietary restrictions and has been put forward as a novel acceptable and safe strategy that has shown promising effects on body weight glucose metabolism appetite and cardiometabolic health in individuals at high risk of T2D
Although it has been suggested that TRE is a safe and feasible intervention the longer-term effectiveness of TRE on glycaemic control and weight loss in individuals with T2D is unknown alongside the long-term acceptability and sustainability Additionally potential social and contextual challenges associated with integration of TRE into ordinary daily life structure and routines call for new approaches to support the individual in implementing and maintaining the strategy
Overall the RESET2 study consists of three phases 1 Need assessment 2 Pilot study and 3 RCT The aim of the present study RCT is to investigate the effectiveness of implementing a 1-year TRE-based intervention in individuals with overweightobesity and T2D Participants will attend 6 visits at Steno Diabetes Center Copenhagen SDCC Visit 0 screening Visit 1 baseline minimum 10 days after screening Visit 2 10 days prior to visit 3 Visit 3 3 months 12 weeks after baseline Visit 4 10 days prior to visit 5 Visit 5 12 months 52 weeks after baseline
The specific objectives are
1 To investigate the effect of a 1-year TRE intervention on changes in glycaemic control HbA1c in individuals with overweightobesity and T2D
2 To investigate the effects of a 1-year TRE intervention on changes in body weight fat mass continuous glucose monitoring CGM recorded time in range TIR 39-100 mmoll and use of antidiabetic medication in individuals with overweightobesity and T2D
3 To describe changes in cardiometabolic risk factors including fat-free mass blood lipids markers of kidney and liver function and inflammation hormones involved in glucose metabolism and appetite control liver fat blood pressure waist- and hip circumference time below range TBR time above range TAB cognition food preferences and reward dim light melatonin onset DLMO and patient-reported outcomes including self-rated health physical activity well-being diabetes distress depression food intake and sleep quality
4 To investigate the effects of a 3-month TRE intervention on changes in brain insulin sensitivity sub-study
5 To describe the extent to which the intervention was conducted as planned visits conversations phone calls peer support activities
6 To describe the extent to which participants participated in support-related activities
7 To explore participants experiences with following TRE throughout a year including how they managed to keep their eating window and how the supporting activities and individualized approach worked for them sub-population
8 To explore the results from objectives 1-7 in relation to the extent the participants adhered to eating windows
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None