Phase
Condition
Diabetes And Hypertension
Diabetes Mellitus Types I And Ii
Diabetes (Pediatric)
Treatment
Very low-carbohydrate diet
Standard NDPP
Clinical Study ID
Ages 21-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
overweight, defined as BMI >= 25 kg/m2 >= 23 kg/m2 if of Asian descent
HbA1c between 5.7% - 6.4% verified at baseline
willingness to participate in group-based sessions
able to engage in at least light physical activities such as walking
willingness to follow a prescribed diet, be randomized, self-weight, track diet, andreport physical activity minutes
physician approval to participate
Exclusion
Exclusion Criteria:
history of type 1 diabetes or type 2 diabetes
use of anti-obesity medications or participation in another weight loss program orintervention
use of glucose lowering medications other than metformin
pregnant or planning to become pregnant during the intervention period
breastfeeding
use of oral corticosteroids
previous bariatric surgery or planning to have bariatric surgery during the studyperiod
blood disorders that influence HbA1c, including frequent blood transfusions,phlebotomy, anemia, hemoglobinopathy, polycythemia
any condition for which the study team deems participation to be unsafe orinappropriate
inability to read, write, or speak English
inability to provide informed consent
adherence to a vegan or vegetarian diet
adherence to a very low-carbohydrate (keto) diet
difficulty chewing or swallowing
no influence over what foods are purchased, prepared, and/or served
above weight limit for DEXA (500 pounds)
untreated eating disorder or mental health conditions, such as depression withsuicidal ideation, bipolar or schizophrenia with psychosis
use of warfarin
chronic kidney disease, stage 4 or higher
use of loop diuretics: 20mg or higher of furosemide or equivalent (Lasix (furosemide), Bumex (bumetanide), Ederin or Sodium Edecrin (ethacrynic acid),Demadex or Soaanz (torsemide))
any concerning values in baseline labs (participants will be referred to PrimaryCare Physician and will be allowed to return for later enrollment if labs are nolonger concerning)
Triglycerides 600 Milligrams per deciliter (mg/dL) or higher
Thyroid stimulating hormone of any abnormal value
Potassium of any abnormal value
Study Design
Connect with a study center
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
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