Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545721
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Weight Cycling on Hyperandrogenemia and Insulin Resistance in Polycystic Ovary Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect and Mechanism Of Weight Cycling on Hyperandrogenemia And Insulin Resistance in Polycystic Ovary Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
WHIP
Brief Summary:
This study prospectively includes PCOS patients with normal weight and overweightobesity closely follows up and intensively manages them and observes the level and distribution of weight reduction achieved by patients after lifestyle intervention high-protein diet for weight loss Additionally it aims to provide reference for setting weight loss targets for future PCOS patients by comparing the differences in clinical improvement among patients achieving different degrees of weight reduction 2 equivalent to no weight loss 2-5 5-10 10 at different time points 3 months 6 months following dietary intervention Furthermore this study will compare the differences in reproductive and metabolic marker improvements between baseline PCOS patients experiencing weight rebound those who successfully lost weight and those who experienced weight rebound This will help explore the impact of weight cycling on PCOS-related manifestations Finally at a genetic level the study will analyze potential mechanisms underlying different outcome indicators by comparing differences in metagenomics transcriptomics and metabolomics among patient groups
Detailed Description:
This study is a single-center prospective cohort study that enrolled PCOS patients after screening The patients were categorized into two groups based on their BMI a normal weight group 185 kgm2 BMI 24 kgm2 with a sample size of 45 and an overweightobese group BMI 24 kgm2 with a sample size of 380 totaling 425 cases
For the normal weight PCOS patients interventions included control of total energy intake adjustment of dietary structure exercise and behavioral intervention to prevent weight gain over a follow-up period of three months If weight gain occurred during the follow-up period these patients were transferred to the overweightobese group for intensified intervention
The overweightobese PCOS patients received intensive intervention in accordance with high-protein diet adaptation criteria This involved high-protein diets combined with exercise and behavioral intervention for weight reduction After three months of follow-up if they achieved their weight-loss goal they transitioned to a low-energy diet and exercise intervention program to maintain their weight If the goal was not met after three months they continued with the high-protein weight-loss program
The study compared differences in improvement in indicators such as insulin resistance IR blood androgen levels inflammatory factors among different degrees of weight loss 2 2 weight loss 5 5weight loss10 10 analyzing potential mechanisms
For individuals experiencing weight cycling differences in IR levels before and after rebounding from body mass were compared alongside changes in androgen levels and other metabolic indicators This aimed to explore the impact of body mass cycling on clinical indicators while analyzing potential causes
For the normal weight PCOS patients interventions included control of total energy intake adjustment of dietary structure exercise and behavioral intervention to prevent weight gain over a follow-up period of three months If weight gain occurred during the follow-up period these patients were transferred to the overweightobese group for intensified intervention
The overweightobese PCOS patients received intensive intervention in accordance with high-protein diet adaptation criteria This involved high-protein diets combined with exercise and behavioral intervention for weight reduction After three months of follow-up if they achieved their weight-loss goal they transitioned to a low-energy diet and exercise intervention program to maintain their weight If the goal was not met after three months they continued with the high-protein weight-loss program
The study compared differences in improvement in indicators such as insulin resistance IR blood androgen levels inflammatory factors among different degrees of weight loss 2 2 weight loss 5 5weight loss10 10 analyzing potential mechanisms
For individuals experiencing weight cycling differences in IR levels before and after rebounding from body mass were compared alongside changes in androgen levels and other metabolic indicators This aimed to explore the impact of body mass cycling on clinical indicators while analyzing potential causes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None