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

Obesity Clinical Trial

— DRS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05397028
• Other study ID #: 5200281
• Status: Terminated
• Phase: N/A
• Start date: December 8, 2022
• Est. completion date: March 14, 2023

Study information

• Verified date: January 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 assess the efficacy of which patients with Type 2 Diabetes (non insulin dependent) can be brought into a optimal A1C remission state without the use of medications by achieving clinically significant weight loss (>20-30 pounds) using a proprietary meal replacement system associated with a 3-month intensive lifestyle program.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 14, 2023
• Est. primary completion date: March 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity

Intervention

Dietary Supplement:
• Meal replacement system
Participants will replace meals with a meal replacement system to assess the efficacy of weight loss leading to remission of diabetes (optimal A1C levels).

Behavioral:
• Intensive lifestyle Intervention
Participants will sign up with a virtual health program which they will interact with.

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of plant-based meal replacement system on A1-C levels	Blood draw to measure the effect of the diet on the A1-C level. Normal A1C is at or below 5.7%. Prediabetes levels range between 5.8%-6.4%. Diabetes is at or above 6.5%.	Change between baseline and six month visit.
Secondary	Efficacy of plant-based meal replacement system on insulin levels	Blood draw to measure the effect of the diet on fasting insulin. Insulin levels under the value 10 are considered normal.	Change between baseline and six month visit.