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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05397028
Other study ID # 5200281
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
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