Status:

TERMINATED

Weight Management for the Remission of Type 2 Diabetes Using a Proprietary Meal Replacement System- Diabetes Remission Study (DRS)

Lead Sponsor:

Loma Linda University

Conditions:

Obesity

Diabetes Mellitus, Type 2

Eligibility:

All Genders

25-65 years

Phase:

NA

Brief Summary

A three month meal replacement dietary system which combines meal replacements and self-prepared meals which hypothetically will result in Diabetes remission in \>30% of intervention subjects To asse...

Eligibility Criteria

Inclusion

  • Men and Women
  • Ages 25-65
  • Have been diagnosed with non-insulin dependent diabetes for less than five years
  • Are taking at least one oral agents for diabetes
  • English speaking

Exclusion

  • Individuals currently being treated for cancer
  • Had a myocardial infarction in the previous 3 months
  • Have uncontrolled persistent hypertension - diastolic \>90 systolic \>160
  • Individuals with established eating disorder diagnoses
  • Individuals who have recent weight loss attempt in the last 3 months with \> 5-pound loss
  • Use of anti-obesity medications in the last three months
  • Individuals who have had bariatric surgery
  • Individuals taking medications that are known to cause weight gain including but not limited to insulin, steroids, haloperidol clozapine, risperidone, olanzapine, amitriptyline imipramine, paroxetine, and lithium
  • Individuals who are pregnant or planning to become pregnant in the next 6 months

Key Trial Info

Start Date :

December 8 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 14 2023

Estimated Enrollment :

3 Patients enrolled

Trial Details

Trial ID

NCT05397028

Start Date

December 8 2022

End Date

March 14 2023

Last Update

January 19 2024

Active Locations (1)

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Loma Linda University Health

Loma Linda, California, United States, 92350