Recruiting

Observational Study

Sponsor:

University of Tennessee

Code:

NCT03832725

Conditions

Newly Diagnosed Type 2 Diabetes

Obese

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Accepted

Interventions

High Protein (HP) weight loss diet

High carbohydrate (HC) weight loss diet

Study Details

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

Study ID

NCT03832725

Start date

Mar 1, 2018

Status verified date

Feb, 2019

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

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%.

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Exclusion Criteria:

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.

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Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: High protein (HP) weight loss diet

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.

active comparator: High carbohydrate (HC) weight loss diet

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

Interventions

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

Primary outcome measure

  • Remission of Type 2 Diabetes [ Time Frame: Each subject will be monitored for 6 months while they are on the HP or HC diet for remission of Type 2 Diabetes ]

Central Contacts and Locations

Central contacts

Frankie B Stentz, PhD

901-448-5803fstentz@uthsc.edu

Locations

University of Tennessee Health Science Center

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

Frankie B Stentz, PhD

901-448-5803fstentz@uthsc.edu

More Information

Sponsor

University of Tennessee

Last update posted

Feb 7, 2019

Last verified

Feb, 2019

Keywords

  • Type 2 Diabetes
  • obesity
  • pathobiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2019-02-07.