Status:
UNKNOWN
Pathobiology of Remission of Type 2 Diabetes
Lead Sponsor:
University of Tennessee
Conditions:
Newly Diagnosed Type 2 Diabetes
Obese
Eligibility:
All Genders
20-50 years
Phase:
NA
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 weigh...
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 prof...
Eligibility Criteria
Inclusion
- 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
- 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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Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03832725
Start Date
March 1 2018
End Date
July 31 2024
Last Update
February 7 2019
Active Locations (1)
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1
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163