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West Lafayette, Indiana 47904


Purpose:

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome.


Study summary:

The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive therapeutic effects would be represented by improved glycemic control in patients with type 2 diabetes without use of additional glycemic control medications and failure to progress to type 2 diabetes in individuals with pre-diabetes and metabolic syndrome. Secondary purposes of this research are to determine if therapeutic effects of the intervention differ between patients who self-select onsite vs. web-based education delivery, explore relationships between change in LDL cholesterol and carotid intima media thickness, and to evaluate the sustainability of health outcomes achieved and the economic impact of therapeutic effects over 5 years.


Criteria:

Inclusion Criteria: Body weight/Diabetes: - Diagnosis of type-2 diabetes with BMI > 25 (without end-organ failure) - Fasting glucose >126 mg/dL or HbA1c >6.5 Body weight/ Pre-diabetes: • Diagnosis of metabolic syndrome with BMI >30 and HbA1c > 5.6 (note: this does not apply to usual care control subjects) Ethnicity: all ethnic groups Exclusion Criteria: - BMI <30 without diagnosis of Type-2 diabetes, metabolic syndrome - Type 1 diabetes - History of keto-acidosis - History of MI, stroke, angina, coronary insufficiency within the last 6 months - Diabetic retinopathy requiring treatment - Creatinine > 2.0 - Urinary albumin > 1 g/d - Impaired hepatic function (Bilirubin >2, Albumin < 3.5) - Cholelithiasis or biliary dysfunction - Cancer requiring treatment in the past 5 years, with the exception of non-melanoma skin cancer - Chronic infectious disease requiring ongoing treatment - Other chronic diseases or condition likely to limit lifespan to <6 years - Non-English speaking - Unable or unwilling to participate in group sessions (e.g., plans to relocate within the next year) or conform to a carbohydrate restricted diet lifestyle (e.g., food intolerances, religious or personal restrictions) - Weight loss of >10% in past 6 months - Currently pregnant or nursing, or planning to become pregnant during the study - Major psychiatric disorder (e.g., schizophrenia, bipolar disorder) currently uncontrolled - Excessive alcohol intake (acute or chronic) defined as average consumption of 3 or more alcohol-containing beverages daily or consumption of more than 14 alcoholic beverages per week


NCT ID:

NCT02519309


Primary Contact:

Principal Investigator
Sarah Hallberg, DO, MS
Indiana University Health


Backup Contact:

N/A


Location Contact:

West Lafayette, Indiana 47904
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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