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.
Conditions:
🦠 Newly Diagnosed Type 2 Diabetes 🦠 Obese
🗓️ Study Start (Actual) 1 March 2018
🗓️ Primary Completion (Estimated) 31 July 2024
✅ Study Completion (Estimated) 31 July 2024
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Memphis, Tennessee, United States

📋 Eligibility Criteria

Description

    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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Ages Eligible for Study: 20 Years to 50 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 February 2019
  • First Submitted that Met QC Criteria 4 February 2019
  • First Posted 6 February 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 February 2019
  • Last Update Posted 7 February 2019
  • Last Verified February 2019