Diabetes Prevention With Lifestyle Intervention and Metformin Escalation

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT03258723
• Date of registration: 20/08/2017
• Prospective Registration: Yes
• Primary sponsor: Yale University
• Public title: Diabetes Prevention With Lifestyle Intervention and Metformin Escalation LIME
• Scientific title: Diabetes Prevention With Lifestyle Intervention and Metformin Escalation
• Date of first enrolment: July 30, 2018
• Target sample size: 114
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03258723
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Barbados, Puerto Rico, Trinidad and Tobago, United States, Virgin Islands (U.S.)

Contacts

• Name: Marcella Nunez-Smith, MD
• Affiliation: Yale University

Key inclusion & exclusion criteria

Inclusion Criteria:

- BMI>25 or WC>88/102cm

- No history of type I or type II diabetes or gestational diabetes

- Not on blood sugar altering medication

- Ability to attend weekly sessions

- HbA1c 6-6.4%

Exclusion Criteria:

- Pregnant

- eGFR<45 mL/min/1.73 m2

- Prescribed Metformin and randomized to the control arm



Age minimum: 40 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes

Intervention(s)

Drug: Metformin

Behavioral: Lifestyle Intervention

Primary Outcome(s)

Change in Hemoglobin A1c (HbA1c) [Time Frame: Baseline and 12 months]

Secondary Outcome(s)

Change in Diastolic Blood Pressure [Time Frame: Baseline and 6 months]

Change in Self-Efficacy Score - Worry Scale [Time Frame: 6 months]

Change in Weight (kg) [Time Frame: Baseline and 6 months]

Change in Fruit and Vegetable Intake (Total Servings) [Time Frame: Baseline and 6 months]

Change in Systolic Blood Pressure [Time Frame: Baseline and 6 months]

Change in Physical Activity Level. [Time Frame: Baseline and 6 months]

Change in Self-Efficacy Score - Personal Control Scale [Time Frame: Baseline and 6 months]

Change in Sugar-sweetened Beverage Intake (Teaspoons Per Day) [Time Frame: Baseline and 6 months]

Diabetes Risk Score [Time Frame: 6 months]

Secondary ID(s)

1U54MD010711-01

2000020105

1K12HL138037-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Institute on Minority Health and Health Disparities (NIMHD)

National Heart, Lung, and Blood Institute (NHLBI)

Results

• Results available: Yes
• Date Posted: 22/12/2022
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03258723