Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533007
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
PDE3B in Metabolic Regulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Role of Phosphodiesterase 3B in the Regulation of Human Adipose Tissue Biology and Systemic Glucose and Lipid Homeostasis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Phosphodiesterase 3B PDE3B an enzyme responsible for the degradation of cyclic AMP and GMP two important second messengers used for intracellular signal transduction has been associated with cardiometabolic outcomes Results from animal studies indicate that abolishing PDE3B function may be associated with unfavourable metabolic profile however preliminary human studies suggest that heterozygous loss of function LoF variants in the PDE3B gene have been associated with cardiometabolic improvements Therefore the effect of PDE3B on human adipose tissue metabolic pathways remains poorly understood
Accordingly the investigators propose to conduct a recall-by-genotype case-control study in a group of people with LoF variants in the PDE3B gene and a matched group without the variant wild type WT to determine differences on key metabolic features 1 adipose tissue biology ie mitochondrial function adipocyte morphology gene expression and in vivo lipolysis in the basal andor the insulin-stimulated state 2 systemic lipid and glucose metabolism using the hyperinsulinemic-euglycemic clamp procedure
The proposed investigations will elucidate the role of PDE3B on adipose tissue and systemic glucose and lipid metabolism in humans and whether modulating PDE3B activity constitutes a target for the prevention and treatment of cardiometabolic disease
Accordingly the investigators propose to conduct a recall-by-genotype case-control study in a group of people with LoF variants in the PDE3B gene and a matched group without the variant wild type WT to determine differences on key metabolic features 1 adipose tissue biology ie mitochondrial function adipocyte morphology gene expression and in vivo lipolysis in the basal andor the insulin-stimulated state 2 systemic lipid and glucose metabolism using the hyperinsulinemic-euglycemic clamp procedure
The proposed investigations will elucidate the role of PDE3B on adipose tissue and systemic glucose and lipid metabolism in humans and whether modulating PDE3B activity constitutes a target for the prevention and treatment of cardiometabolic disease
Detailed Description:
Phosphodiesterase 3B PDE3B is a protein that plays a role in how cells handle nutrients ie glucose and fats The investigators have recently found that people who have a gene variant ie change in the DNA that reduces the function of the PDE3B protein may be protected from the development of diabetes and heart disease However it is unclear how this happens
The aims of this study are to examine
What is the role of PDE3B in fat tissue function
How does PDE3B influence the way ones body handles blood sugars and lipids
To this end the investigators propose to study people who have a variant that reduces the function of that PDE3B and an equal number of people with the typical genotype
Participants will be asked to attend two visits
a 4-h screening visit involving a medical examination blood tests beforeafter drinking a sugary drink and assessment of lifestyle physical activitysleepdiet using questionnaires and smartwatch
a 24-h metabolic testing visit only for eligible participants involving an infusion of insulin and collection of blood samples and fat tissue from the lower tummy
These investigations will provide a great opportunity to study how people with or without the variant handle fat sugars and lipids in their bodies They will also help the scientific community to understand the role of PDE3B in humans and possibly develop new ways to prevent or fight conditions like diabetes and heart disease
The aims of this study are to examine
What is the role of PDE3B in fat tissue function
How does PDE3B influence the way ones body handles blood sugars and lipids
To this end the investigators propose to study people who have a variant that reduces the function of that PDE3B and an equal number of people with the typical genotype
Participants will be asked to attend two visits
a 4-h screening visit involving a medical examination blood tests beforeafter drinking a sugary drink and assessment of lifestyle physical activitysleepdiet using questionnaires and smartwatch
a 24-h metabolic testing visit only for eligible participants involving an infusion of insulin and collection of blood samples and fat tissue from the lower tummy
These investigations will provide a great opportunity to study how people with or without the variant handle fat sugars and lipids in their bodies They will also help the scientific community to understand the role of PDE3B in humans and possibly develop new ways to prevent or fight conditions like diabetes and heart disease
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