Status:
COMPLETED
A Low-Carbohydrate Diabetes Prevention Program
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Kidney Foundation, United States
Conditions:
PreDiabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The investigators will conduct a single-arm mixed methods pilot study to estimate weight loss as well as the percentage of participants who achieve 5% weight loss in a 16-week, Low-Carbohydrate Diabet...
Detailed Description
An estimated 86 million US adults are have prediabetes, and, without intervention, many will develop T2DM over time. Fortunately, T2DM can be prevented or delayed through modest lifestyle changes. The...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Overweight, defined as BMI≥25 kg/m2 \[31\]
- HbA1c between 5.7-6.4% drawn within 6 months of the study start date
- Willingness to participate in group-based classes
- Able to engage in at least light physical activities such as walking.
- Exclusion criteria:
- History of type 1 diabetes or type 2 diabetes
- Current participation in another lifestyle or behavior change program or research study
- Vegetarian or vegan lifestyle
- History of bariatric surgery
- Inability to read, write, or speak English
- Inability to provide informed consent
- Women who are pregnant or intend to become pregnant during the intervention period.
- Insured by Premier Care or Grad Care; these individuals have the opportunity to participate in a standard DPP, which is offered as a covered benefit through their health plan.
Exclusion
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2018
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03258918
Start Date
September 11 2017
End Date
November 7 2018
Last Update
December 12 2018
Active Locations (1)
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1
Michigan Medicine
Ann Arbor, Michigan, United States, 48109