Clinical Trial

Pathobiology of Remission of Type 2 Diabetes

Study Description

Pathobiology of Remission of Type 2 Diabetes

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: (a)remission of NT2DM to Normal Glucose Tolerance(NGT), (b)weight loss, (c)improvements in metabolic markers, Cardiovascular Risk Factors(CVR), 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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

High Protein (HP) weight loss diet

Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HP diet for 6 months with all food provided for weight loss and remission of NT2DM. Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment

High carbohydrate (HC) weight loss diet

Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HC diet for 6 months with all food provided for weight loss and remission of NT2DM. Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment

Additional Information

Official Study Title

Pathobiology of Remission of Type 2 Diabetes

Clinical Trial ID

NCT03832725

ParticipAid ID

egJXZd