Pathobiology of Remission of Type 2 Diabetes

NCT03832725 | Unknown DMC

• 1 other identifier: UTennHSCFS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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: (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.

Conditions

Newly Diagnosed Type 2 Diabetes; Obese

Keywords

Type 2 Diabetes; obesity; pathobiology

Outcome Measures

Primary Outcomes (1)

• Remission of Type 2 Diabetes

  Remission of NT2DM to NGT will be determined by the OGTT ( a 75 gm glucose drink given at 0 minutes and then blood drawn to determine the glucose level at 2 hrs). This OGTT will be done at 3 and 6 months with the criteria of fasting glucose \<126 mg/l and 2 hour glucose \<140 mg/dl. Criteria for improvement from NT2DM to IGT will be fasting blood glucose \<126 mg/dl and 2 hour glucose \<199 mg/dl. At each weekly visit for food pick up the subject's glucose will be monitored for blood glucose changes from the start of the diet study. If subjects do not have remission of diabetes at 6 months, they will be referred to an endocrinologist for possible pharmacology treatment.

  Each subject will be monitored for 6 months while they are on the HP or HC diet for remission of Type 2 Diabetes

Secondary Outcomes (4)

• Weight loss

  Each subject will be monitored for 6 months while they are on the HP or HC diet

• Cardiovascular Risk Factors (CVR)

  Each subject will be monitored for 6 months while they are on the HP or HC diet

• Inflammation markers such as cytokines,

  Each subject will be monitored for 6 months while they are on the HP or HC diet

• Metabolom Markers

  Each subject will be monitored for 6 months while they are on the HP or HC diet

Study Arms (2)

High protein (HP) weight loss diet

ACTIVE COMPARATOR

A weight loss high protein (HP) (30% Kcal protein, 40% Kcal carbohydrate (CHO) and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months.

Other: High Protein (HP) weight loss diet

High carbohydrate (HC) weight loss diet

ACTIVE COMPARATOR

A weight loss high carbohydrate (HC) (15% Kcal protein, 55% Kcal CHO and 30% Kcal fat) diet will be given to the subjects on that arm of study to pick up weekly for 6 months. Intervention with the HC 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

Other: High carbohydrate (HC) weight loss diet

Interventions

High Protein (HP) weight loss diet OTHER

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 protein (HP) weight loss diet

High carbohydrate (HC) weight loss diet OTHER

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

High carbohydrate (HC) weight loss diet

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• i) Age range 20 yrs to 50 yrs; ii) BMI \> 30 kg/m2 to 55kg/m2; iii). Fasting blood glucose \>126 mg/dl and 2 hour glucose \>200 mg/dl determined by OGTT; iv). HbA1c \> 6.5 % to ≤10%.

You may not qualify if:

• i) Proteinuria or elevated serum creatinine (\>1.5 mg/dl); ii) Surgical or premature menopause; iii) liver disease or abnormal liver function tests; iv) T2DM of greater than 2 yrs; v) Thyroid disease with abnormal TSH; vi) Weight \> 350 lbs, (due to fit on DXA); vii) Triglycerides\>400 mg/dl or LDL cholesterol \>160 mg/dl; viii) SBP\>145, DBP\>100 mm of Hg; ix) on medications known to effect lipid or glucose metabolism; x) Pregnancy or become pregnant in next 6 mo; xi) Weight loss \>10% of body weight in last 6 mo; xii)History of cancer \<5 yrs or undergoing active treatment; xiii) smoking, xiv)alcohol abuse; xv) having CPAP treatment. xvi)Subjects with HbA1c \>10% will be referred to an endocrinologist for pharmacological treatment.

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

Diet, Reducing

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Frankie B Stentz, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frankie B Stentz, PhD

CONTACT

901-448-5803; fstentz@uthsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Subjects or investigators will not know which macronutrient diet (high protein or high carbohydrate) which they are given for the study.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor/ Department of Medicine/Endocrinology, Diabetes and Metabolism

Model Details: Subjects will be randomized to a macronutrient high protein or high carbohydrate diet provided by the study for weight loss and remission of Type 2 Diabetes

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 6, 2019
• Study Start: March 1, 2018
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Over the time frame of the study
• Access Criteria: contact investigator

Locations

US (1)