Ignite Creation Date:
2024-05-06 @ 12:44 PM
Last Modification Date:
2024-10-26 @ 1:03 PM
Study NCT ID:
NCT03832725
Status:
UNKNOWN
Last Update Posted:
2019-02-07
First Post:
2019-02-01
Brief Title:
Pathobiology of Remission of Type 2 Diabetes
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Pathobiology of Remission of Type 2 Diabetes
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
RECRUITING
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:
We propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM NT2DM women and men for 6 months for remission of Type 2 Diabetes Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians clinics and metabolomics predictors for assessment of remission The overall objective of this study is to determine if remission of NT2DM can be induced by dietary manipulation using a HP diet and the pathobiology of this remission We hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and daily menus for compliance The rationale is the HP diet is palatable for subjects to continue after the 6 month study and stay in remission using diet plans we provide We will compare the effects of the HP vs HC diet on remission Specific aims of this study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 month feeding study and determine aremission of NT2DM to Normal Glucose ToleranceNGT bweight loss cimprovements in metabolic markers Cardiovascular Risk FactorsCVR and inflammation markers and epigenetic DNA methylation changes and pathways involved with remission and metabolomic markers to establish predictive markers of remission of NT2DM We propose to use a non-pharmaceutical means HP diet for remission of T2DM and weight loss and determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with emerging technologies The proposed research is significant because if we can demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic improvements it would be a significant improvement in health risk and medical cost to subjects
Detailed Description:
Greater than 30 million people have diabetes Over time diabetic patients need more and more medications and develop numerous medical complications Remission of Type 2 Diabetes T2DM would have profound effects on people with diabetes with respect to overall health improvement insulin sensitivitySi cardiovascular risk factorsCVR inflammation markers IC reduction of retinopathy nephropathy neuropathy and reduction in medical costs Methods to accomplish this have not yet been determined however it is generally accepted that non-drug methods to treat T2DM is the most cost effective and have the fewest side effects The primary risk factor for T2DM is obesity Our randomized clinical trials comparing the effects of High Protein HP vs High Carbohydrate HC weight loss diets in obese prediabeticIGT women and men where all foods were provided daily for 6 monthsmo showed that while both diet groups had similar weight loss 100 of HP diet subjects had remission from IGT to Normal Glucose ToleranceNGT but only 33 of HC diet group had remission Also the HP diet provided greater improvement in Si CVR IC and an increase in lean body mass LBM compared to the HC diet demonstrating that weight loss is not the only factor involved in remission Based on these findings we now propose to investigate effects of HP and HC weight loss diets in Newly Diagnosed T2DM NT2DM women and men for 6 mo Our long term goal is to establish a weight loss diet plan for remission of NT2DM which would be adaptable for use in physicians clinics and metabolomics predictors for assess-ment of remission The overall objective of this study is to determine if remission of NT2DM can be induced by dietary manipulation using a HP diet and the pathobiology of this remission We hypothesize that NT2DM subjects will have remission to NGT on the HP diet when they are provided the food and daily menus for compliance The rationale is the HP diet is palatable for subjects to continue after the 6 mo study and stay in remission using diet plans we provide We will compare the effects of the HP vs HC diet on remission Specific aims of this study are to determine the effects of the HP and HC diets on NT2DM obese subjects in a 6 mo feeding study and determine aremission of NT2DM to NGT bweight loss and LBM preservation cimprovements in metabolic markers CVRs IC epigenetic DNA methylation changes and pathways involved with remission and metabolomic markers to establish predictive markers of remission of NT2DM This study is innovative in that we propose to use a non-pharmaceutical means HP diet for remission of T2DM diabetes and weight loss and determine the pathobiology involved in improvement in metabolic and CVRs by interrogating the samples with emerging technologies The proposed research is significant because if we can demonstrate the HP diet cause remission of NT2DM to NGT along with other metabolic improvements it would be a significant improvement in health risk and medical cost to subjects
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