Diabetes Mellitus, Type 2, Obesity
Conditions
Keywords
obesity, Diabetes, Type 2, meal replacement, diabetes remission
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 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.
Interventions
DIETARY_SUPPLEMENTMeal 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).
BEHAVIORALIntensive lifestyle Intervention
Participants will sign up with a virtual health program which they will interact with.
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of plant-based meal replacement system on A1-C levels | Change between baseline and six month visit. | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of plant-based meal replacement system on insulin levels | Change between baseline and six month visit. | Blood draw to measure the effect of the diet on fasting insulin. Insulin levels under the value 10 are considered normal. |
Countries
United States
Outcome results
None listed