Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06050265
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-09-15
Brief Title:
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Glucose Evaluation Through Continuous Glucose Monitors in Polycystic Ovary Syndrome
Status:
RECRUITING
Status Verified Date:
2023-11
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:
GEMS-PCOS
Brief Summary:
PCOS is the most common endocrine disorder of reproductive aged women In addition to menstrual and endocrine abnormalities PCOS is characterized by insulin resistance and glycemic dysregulation The pattern of glycemic abnormalities among patients with PCOS may be different than the general population as evidenced by invasive time consuming and costly procedures such as the euglycemic clamp or oral glucose tolerance test Continuous glucose monitoring CGM offers an opportunity to evaluate glycemic status in real world conditions Furthermore use of a CGM has been found to improve glycemic status among those with prediabetes and diabetes but little is known about utility among patients with PCOS The investigators thus seek to 1 characterize glycemic status using CGM among patients with PCOS and 2 assess the impact of CGM use on metabolic and reproductive health in patients with PCOS
Detailed Description:
Study synopsis
Recruitment
PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic
Non-PCOS participants will be recruited from patients being seen at the UCSF Center for Reproductive Health for other clinical evaluations or research projects
Study protocol
Aim 1
Pre-DEXCOM evaluation
PCOS participants
As part of routine clinical care all PCOS participants will have had the following procedures completed
Blood work for fasting and 2 hour glucoseinsulin hgba1c CRP lipid panel liver enzymes SHBG free and total testosterone DHEAS androstenedione 17-OH-Progesterone prolactin TSH FSH LH E2 estrone Vit D
Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire
In person clinical evaluation including physical exam and history
In person transvaginal ultrasound assessment
The above are part of standard of care screening for patients with concern for PCOS and are currently routinely completed at the UCSF Center for Reproductive Health in this setting
Participants will also be asked to complete a 10 question validated fatigue assessment scale FAS
Non-PCOS participants
Participants will have blood work for fasting and 2 hour glucoseinsulin hgba1c CRP lipid panel liver enzymes SHBG free and total testosterone DHEAS androstenedione 17-OH- Progesterone prolactin TSH FSH LH E2 estrone Vit D obtained
Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire will be obtained
Participants will be asked to complete the same intake questionnaires that PCOS participants complete as part of standard of care practices in the UCSF multidisciplinary PCOS clinic which include questions on ethnicity family medical and social history
If blood work was not completed as part of standard of care for routine clinical evaluation or as part of a previously completed research study in which the patient provided consent for their data to be used in other trials the above labs will be collected and paid for by the research protocol
Participants will also be asked to complete a 10 question validated fatigue assessment scale FAS
Procedures
DEXCOM evaluation
PCOS and non-PCOS participants will be given a DEXCOM CGM to wear for 10 days During this time they will be blinded to the results of the DEXCOM
Participants will be asked to complete the automated self-administered 24-hour dietary assessment ASA24 tool which is a web based validated 24 hour dietary record program produced by the National Cancer Institute NCINation Institute of Health and made available free of charge to researchers
As part of the ASA24 participants will also be asked about their sleep quality the night prior to their dietary record See attached module
All participants will be asked to complete the ASA24 during a 24 hour period while wearing the CGM
Aim 2
Recruitment
From those participants with PCOS recruited for Aim 1 a subgroup with evidence of dysglycemia as outlined in the inclusion criteria will be recruited for aim 2
Participants will be randomized in a 31 fashion to intervention with CGM vs control
Procedures
Intervention group
All participants will receive standard of care nutrition and exercise advice from a trained registered dietician
Participants randomized to the intervention arm will also receive education on how to use and monitor blood glucose using the DEXCOM G7 CGM and associated phone application
Participants will be asked to use a CGM continuously for 90 days
After 90 days blood work for fasting and 2 hour glucoseinsulin hgba1c CRP lipid panel liver enzymes SHBG free and total testosterone DHEAS androstenedione 17-OH-Progesterone prolactin TSH FSH LH E2 estrone Vit D will be obtained
After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale FAS
After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period
Control group
All participants will receive standard of care nutrition and exercise advice from a trained registered dietician
After 90 days blood work for fasting and 2 hour glucoseinsulin hgba1c CRP lipid panel liver enzymes SHBG free and total testosterone DHEAS androstenedione 17-OH-Progesterone prolactin TSH FSH LH E2 estrone Vit D will be obtained
After 90 days participants in the control group will be given the opportunity to receive CGM devices to monitor blood glucose up to 30 days with education on how to use the device and associated phone application to monitor blood glucose
After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale FAS
After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period
Data Management
Clinical and laboratory data will be stored in a Research Electronic Data Capture REDCap system designed by Dr Huddleston and research staff Fields will be designed by study coordinators with input from key investigators Our team has extensive experience with REDCap architecture and utilization
Recruitment
PCOS participants will be recruited from those who are being seen or have previously been seen at the UCSF multidisciplinary PCOS clinic
Non-PCOS participants will be recruited from patients being seen at the UCSF Center for Reproductive Health for other clinical evaluations or research projects
Study protocol
Aim 1
Pre-DEXCOM evaluation
PCOS participants
As part of routine clinical care all PCOS participants will have had the following procedures completed
Blood work for fasting and 2 hour glucoseinsulin hgba1c CRP lipid panel liver enzymes SHBG free and total testosterone DHEAS androstenedione 17-OH-Progesterone prolactin TSH FSH LH E2 estrone Vit D
Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire
In person clinical evaluation including physical exam and history
In person transvaginal ultrasound assessment
The above are part of standard of care screening for patients with concern for PCOS and are currently routinely completed at the UCSF Center for Reproductive Health in this setting
Participants will also be asked to complete a 10 question validated fatigue assessment scale FAS
Non-PCOS participants
Participants will have blood work for fasting and 2 hour glucoseinsulin hgba1c CRP lipid panel liver enzymes SHBG free and total testosterone DHEAS androstenedione 17-OH- Progesterone prolactin TSH FSH LH E2 estrone Vit D obtained
Screening questionnaires on physical exercise using validated International Physical Activity Questionnaire will be obtained
Participants will be asked to complete the same intake questionnaires that PCOS participants complete as part of standard of care practices in the UCSF multidisciplinary PCOS clinic which include questions on ethnicity family medical and social history
If blood work was not completed as part of standard of care for routine clinical evaluation or as part of a previously completed research study in which the patient provided consent for their data to be used in other trials the above labs will be collected and paid for by the research protocol
Participants will also be asked to complete a 10 question validated fatigue assessment scale FAS
Procedures
DEXCOM evaluation
PCOS and non-PCOS participants will be given a DEXCOM CGM to wear for 10 days During this time they will be blinded to the results of the DEXCOM
Participants will be asked to complete the automated self-administered 24-hour dietary assessment ASA24 tool which is a web based validated 24 hour dietary record program produced by the National Cancer Institute NCINation Institute of Health and made available free of charge to researchers
As part of the ASA24 participants will also be asked about their sleep quality the night prior to their dietary record See attached module
All participants will be asked to complete the ASA24 during a 24 hour period while wearing the CGM
Aim 2
Recruitment
From those participants with PCOS recruited for Aim 1 a subgroup with evidence of dysglycemia as outlined in the inclusion criteria will be recruited for aim 2
Participants will be randomized in a 31 fashion to intervention with CGM vs control
Procedures
Intervention group
All participants will receive standard of care nutrition and exercise advice from a trained registered dietician
Participants randomized to the intervention arm will also receive education on how to use and monitor blood glucose using the DEXCOM G7 CGM and associated phone application
Participants will be asked to use a CGM continuously for 90 days
After 90 days blood work for fasting and 2 hour glucoseinsulin hgba1c CRP lipid panel liver enzymes SHBG free and total testosterone DHEAS androstenedione 17-OH-Progesterone prolactin TSH FSH LH E2 estrone Vit D will be obtained
After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale FAS
After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period
Control group
All participants will receive standard of care nutrition and exercise advice from a trained registered dietician
After 90 days blood work for fasting and 2 hour glucoseinsulin hgba1c CRP lipid panel liver enzymes SHBG free and total testosterone DHEAS androstenedione 17-OH-Progesterone prolactin TSH FSH LH E2 estrone Vit D will be obtained
After 90 days participants in the control group will be given the opportunity to receive CGM devices to monitor blood glucose up to 30 days with education on how to use the device and associated phone application to monitor blood glucose
After 90 days participants will also be asked to repeat a 10 question validated fatigue assessment scale FAS
After 90 days participants will be asked about their menstrual cycle pattern over the 90 day period
Data Management
Clinical and laboratory data will be stored in a Research Electronic Data Capture REDCap system designed by Dr Huddleston and research staff Fields will be designed by study coordinators with input from key investigators Our team has extensive experience with REDCap architecture and utilization
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None