Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06177210
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-11
Brief Title:
Type 2 Diabetes Remission
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Putting Type 2 Diabetes Into Remission Developing a Person-centred Interdisciplinary Nutrition Intervention
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
The study aims to establish a cohort of patients with type 2 diabetes T2D who have achieved remission through lifestyle intervention or bariatric surgery Remission is defined as a return of HbA1c to less than 65 that occurs spontaneously or following an intervention and in the absence of usual glucose-lowering pharmacotherapy for at least 3 months
Detailed Description:
The first aim of the study will be to recruit individuals initial recruitment N10-12 per group with physician diagnosed T2D who have achieved remission HbA1c less than 65 and absence of glucose-lowering pharmacotherapy for at least 3 months through lifestyle interventions or bariatric surgery
Participants will be recruited by Dr Oliveira
from past trials from previous Informed consent document with ethics approval Dr Oliveira will approach participants directly through individual email to advise them that a study is being conducted and to enquire if the participant would like to find out more information concerning it
via partnerstakeholder networks - Healthcare professionals eg private physician dietitian or pharmacist offices permission to release the contact information will be obtained from the participant by the healthcare professionals before the researcher can use the information for recruitment purposes The healthcare professionals will either verbally ask the prospective participants permission to release their names to the Investigator or distribute an introductory letter describing the study to the prospective participants with details on how to contact the Investigator if they are interested in participating
online advertising the recruitment poster as per section 9 will be posted on local online newspapers and by posting Recruitment poster on social media
website recruitment httpsdiabeticstudynetindexhtm
In Manitoba via a recruitment poster as per section 9 that will be circulated via social media and a Letter of initial contact which will be sent to people who express interest in participating
Inclusion criteria
1 Have previously been diagnosed with T2D
2 Have achieved diabetes remission HbA1c below 65 and no glucose lowering medications for at least 3 monthsthrough lifestyle intervention or Bariatric surgery
Exclusion criteria
1 Have not been diagnosed with T2D
2 Have an HbA1c level higher than 65
3 Are taking any glucose lowering medications
4 Are ongoing medical treatment for diseases such as cancer auto-immune or inflammatory disease liver or kidney disorders
5 Are unable to follow remote guidance by internet or smartphone
6 Are unable to read or communicate in English
If demonstrated interest participants will receive a copy of the Informed Consent by email for their review If agreed exclusion and inclusion criteria will be then assessed by completion of an Eligibility Questionnaire and upon confirmation of eligibility an Electronic Consent form will be signed The lead researchers will then ensure that the participants understand the details of the study via phone or Zoom call while asking for confirmation of remission status based on a recent within 1 month laboratory A1c value which is routinely collected by family physicians as part of T2D care Participants in BC without a current laboratory A1c value will be suggested to ask for an exam request from their family doctor
Participants will then answer a package of questionnaires
1 Health Screening Questionnaire Remission Survey Lifestyle intervention or Bariatric surgery
2 Pittsburgh Sleep Quality Index PSQI
3 Godin-Shephard Leisure-Time Physical Activity Questionnaire GSLTPAQ
4 EQ-5D-5L - Describe and Value Health
5 Three-Factor Eating Questionnaire
6 Perceived Stress Scale
All questionnaires and forms will be sent by REDCap-UBC links and are designed to capture baseline characteristics related to T2D and lifestyle that could influence or be influenced by remission
The second aim of the study is to determine glucose profiles of participants from both groups through CGM
Participants will receive a study kit at their homes containing a FreeStyle Libre IQ - Continuous Glucose Monitor CGM Reader and Sensor Diet Record papers and a pre-paid mail envelope CGM instructions will be sent with the kit and a Zoom meeting can be scheduled to help participants with self-insertion of the device which is designed to be inserted by persons living with T2D on their own After completion of the 14-day use the CGM sensor and reader will be sent back by mail CGM will serve to confirm some glucose remission criteria stated by the Consensus Report from American Diabetes Association1 mean daily glucose 70 mmolL and 24-h mean glucose concentrations as an estimated HbA1c eA1C or most recently named as a glucose management indicator GMI 65 The research team is experienced in CGM data collection and analyses having conducted 10 CGM-based studies in the last 8 years1011 Once CGM data are analyzed the research team with follow-up with a Zoom interview in a subsample n4-6 of participants in each remission strategy group lifestyle vs surgery at each site n24 in total The semi-structured interview will consist of questions that investigate what were the person-level challenges and solutions toward achieving T2D remission Participants will self-identify in the original consent form if they are willing to participate in the interview portion and the qualitative participants will be recruited based on the lowest and highest values from the CGM analysis either mean glucose time-in-range or glucose standard deviation whichever gives the largest distribution the highest and lowest 2-3 from each group bariatric surgery vs lifestyle at each site will constitute the sub-sample
The third aim of the study will be to combine these data with our teams expertise in dietetics psychologybehavior change and healthcare delivery and develop an intervention that meets the needs of patients and healthcare providers that can be embedded into the healthcare system
The fourth aim Annual follow-up is to contact participants from T2D remission cohort for subsequent follow-up after 1 year Only participants who consented for future contact and potential future sub-studies that may be conducted once the cohort is established as per Informed Consent page 5 will be approached Participation in follow-up study will not be mandatory Protocol will be similar to first aim study
Participants will be recruited by Dr Oliveira
from past trials from previous Informed consent document with ethics approval Dr Oliveira will approach participants directly through individual email to advise them that a study is being conducted and to enquire if the participant would like to find out more information concerning it
via partnerstakeholder networks - Healthcare professionals eg private physician dietitian or pharmacist offices permission to release the contact information will be obtained from the participant by the healthcare professionals before the researcher can use the information for recruitment purposes The healthcare professionals will either verbally ask the prospective participants permission to release their names to the Investigator or distribute an introductory letter describing the study to the prospective participants with details on how to contact the Investigator if they are interested in participating
online advertising the recruitment poster as per section 9 will be posted on local online newspapers and by posting Recruitment poster on social media
website recruitment httpsdiabeticstudynetindexhtm
In Manitoba via a recruitment poster as per section 9 that will be circulated via social media and a Letter of initial contact which will be sent to people who express interest in participating
Inclusion criteria
1 Have previously been diagnosed with T2D
2 Have achieved diabetes remission HbA1c below 65 and no glucose lowering medications for at least 3 monthsthrough lifestyle intervention or Bariatric surgery
Exclusion criteria
1 Have not been diagnosed with T2D
2 Have an HbA1c level higher than 65
3 Are taking any glucose lowering medications
4 Are ongoing medical treatment for diseases such as cancer auto-immune or inflammatory disease liver or kidney disorders
5 Are unable to follow remote guidance by internet or smartphone
6 Are unable to read or communicate in English
If demonstrated interest participants will receive a copy of the Informed Consent by email for their review If agreed exclusion and inclusion criteria will be then assessed by completion of an Eligibility Questionnaire and upon confirmation of eligibility an Electronic Consent form will be signed The lead researchers will then ensure that the participants understand the details of the study via phone or Zoom call while asking for confirmation of remission status based on a recent within 1 month laboratory A1c value which is routinely collected by family physicians as part of T2D care Participants in BC without a current laboratory A1c value will be suggested to ask for an exam request from their family doctor
Participants will then answer a package of questionnaires
1 Health Screening Questionnaire Remission Survey Lifestyle intervention or Bariatric surgery
2 Pittsburgh Sleep Quality Index PSQI
3 Godin-Shephard Leisure-Time Physical Activity Questionnaire GSLTPAQ
4 EQ-5D-5L - Describe and Value Health
5 Three-Factor Eating Questionnaire
6 Perceived Stress Scale
All questionnaires and forms will be sent by REDCap-UBC links and are designed to capture baseline characteristics related to T2D and lifestyle that could influence or be influenced by remission
The second aim of the study is to determine glucose profiles of participants from both groups through CGM
Participants will receive a study kit at their homes containing a FreeStyle Libre IQ - Continuous Glucose Monitor CGM Reader and Sensor Diet Record papers and a pre-paid mail envelope CGM instructions will be sent with the kit and a Zoom meeting can be scheduled to help participants with self-insertion of the device which is designed to be inserted by persons living with T2D on their own After completion of the 14-day use the CGM sensor and reader will be sent back by mail CGM will serve to confirm some glucose remission criteria stated by the Consensus Report from American Diabetes Association1 mean daily glucose 70 mmolL and 24-h mean glucose concentrations as an estimated HbA1c eA1C or most recently named as a glucose management indicator GMI 65 The research team is experienced in CGM data collection and analyses having conducted 10 CGM-based studies in the last 8 years1011 Once CGM data are analyzed the research team with follow-up with a Zoom interview in a subsample n4-6 of participants in each remission strategy group lifestyle vs surgery at each site n24 in total The semi-structured interview will consist of questions that investigate what were the person-level challenges and solutions toward achieving T2D remission Participants will self-identify in the original consent form if they are willing to participate in the interview portion and the qualitative participants will be recruited based on the lowest and highest values from the CGM analysis either mean glucose time-in-range or glucose standard deviation whichever gives the largest distribution the highest and lowest 2-3 from each group bariatric surgery vs lifestyle at each site will constitute the sub-sample
The third aim of the study will be to combine these data with our teams expertise in dietetics psychologybehavior change and healthcare delivery and develop an intervention that meets the needs of patients and healthcare providers that can be embedded into the healthcare system
The fourth aim Annual follow-up is to contact participants from T2D remission cohort for subsequent follow-up after 1 year Only participants who consented for future contact and potential future sub-studies that may be conducted once the cohort is established as per Informed Consent page 5 will be approached Participation in follow-up study will not be mandatory Protocol will be similar to first aim study
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