Ignite Creation Date:
2024-05-06 @ 1:38 PM
Last Modification Date:
2024-10-26 @ 1:18 PM
Study NCT ID:
NCT04088981
Status:
SUSPENDED
Last Update Posted:
2023-11-07
First Post:
2019-09-06
Brief Title:
Effect of a Dietary Intervention on Intracellular Lipid Levels Insulin Sensitivity and Glycemic Control in Type 2 Diabetes
Sponsor:
Physicians Committee for Responsible Medicine
Organization:
Physicians Committee for Responsible Medicine
Study Overview
Official Title:
Physicians Committee for Responsible Medicine a Randomized Crossover Trial of the Effect of a Dietary Intervention on Intracellular Lipid Insulin Sensitivity and Glycemic Control in Type 2 Diabetes
Status:
SUSPENDED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was not initiated due to COVID-19 restrictions
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the effects of a low-fat plant-based dietary intervention and a portion-controlled dietary intervention compliant with current American Diabetes Association ADA guidelines on changes in intramyocellular and hepatocellular lipid content in adults with type 2 diabetes Changes in insulin sensitivity and glycemic control will also be assessed in this study The study duration is 44 weeks
Detailed Description:
Type 2 diabetes is a disease characterized by discordance between the amount of insulin produced by pancreatic β-cells and the amount of insulin required to overcome insulin resistance in the liver and peripheral tissues The development of insulin resistance has been strongly associated with the prolonged accumulation of lipids fats in the liver cells hepatocellular lipid and muscle cells intramyocellular lipid Conventional pharmacologic therapeutics for type 2 diabetes like metformin are designed to reduce the accumulation of hepatocellular and intramyocellular lipids and thereby augment insulin sensitivity Research has shown that a low-fat plant-based diet in which the consumption of lipids is limited is a similarly effective therapeutic intervention for the reduction of hepatocellular and intramyocellular lipid content and the improvement of insulin sensitivity in type 2 diabetes
The purpose of this study is to compare the effects of low-fat plant-based dietary intervention and a portion-controlled dietary intervention compliant with current American Diabetes Association ADA guidelines on hepatocellular and intramyocellular lipid content in adults with type 2 diabetes Using a cross-over design participants with type 2 diabetes will be randomly assigned to start with a plant-based or a portion-controlled diet for 22 weeks The two groups will then switch to the opposite diet regimen for an additional 22 weeks Before and after each intervention period the investigators will measure intramuscular and liver fat content The investigators will also assess the relationship between these variables insulin sensitivity and glycemic control
The investigators hypothesize that both dietary interventions will result in reductions in intramuscular and liver fat content and that these changes will be associated with improvements in insulin sensitivity and glycemic control in individuals with type 2 diabetes The investigators further hypothesize that the low-fat plant-based dietary intervention will elicit greater changes in intracellular lipid concentration compared with the portion-controlled dietary intervention
The purpose of this study is to compare the effects of low-fat plant-based dietary intervention and a portion-controlled dietary intervention compliant with current American Diabetes Association ADA guidelines on hepatocellular and intramyocellular lipid content in adults with type 2 diabetes Using a cross-over design participants with type 2 diabetes will be randomly assigned to start with a plant-based or a portion-controlled diet for 22 weeks The two groups will then switch to the opposite diet regimen for an additional 22 weeks Before and after each intervention period the investigators will measure intramuscular and liver fat content The investigators will also assess the relationship between these variables insulin sensitivity and glycemic control
The investigators hypothesize that both dietary interventions will result in reductions in intramuscular and liver fat content and that these changes will be associated with improvements in insulin sensitivity and glycemic control in individuals with type 2 diabetes The investigators further hypothesize that the low-fat plant-based dietary intervention will elicit greater changes in intracellular lipid concentration compared with the portion-controlled dietary intervention
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