Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Shared Decision Making Intervention for Diabetes Prevention in Women With a History of Gestational Diabetes Mellitus
Our goal is to test whether shared decision making for diabetes prevention can help women with a history of gestational diabetes mellitus (GDM) who are at high risk of developing type 2 diabetes (T2DM) increase weight loss and adoption of evidence based strategies to lower their risk of incident diabetes.
Status | Recruiting |
Enrollment | 310 |
Est. completion date | October 1, 2026 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 54 Years |
Eligibility | Inclusion Criteria: - BMI 25 kg/m2 or above (23 or above if Asian American woman) - History of gestational diabetes mellitus - History of prediabetes in prior 36 months defined by either 1) most recent HbA1c 5.7-6.4% or 2) most recent FPG 100-125 mg/dL or 3) prior diabetes diagnostic codes + abnormal labs - Patient at UCLA or Intermountain Healthcare Systems with provider visit or labs in prior 12 months Exclusion Criteria: - Delivery within prior 12 months - History of diabetes (i.e., prior HbA1c 6.5% or above, or 2 or more fasting plasma glucose 125 or above, or prior diagnostic code) - Use of an anti-glycemic medication in prior 12 months - Last available glomerular filtration rate (eGFR) <45 ml/min - BMI >60 kg/m2 - Bariatric surgery with prior 12 months - Active eating disorder - Currently pregnant or planning to get pregnant in the next 12-24 months - Completed a prediabetes SDM consult in past - Currently enrolled in a CDC recognized Diabetes Prevention Program (DPP) - Inability or concerns about doing >150 minutes of physical activity per week - History of metformin intolerance - Non-English primary language |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Los Angeles | Los Angeles | California |
United States | Intermountain Healthcare System | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles | Intermountain Health Care, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight change | Proportion with >5% weight loss | 12 months | |
Secondary | Weight Change | Proportion with >5% weight loss | 24 months | |
Secondary | Uptake of DPP lifestyle program or metformin | 1) Attending at least 9 of 16 of weekly lifestyle change sessions OR 2) Taking metformin (yes/no) | 6 months | |
Secondary | Health-related quality of life | Short-form (SF-36) measure | 6, 12, and 24 months |
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