An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
Withdrawn before enrolling · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
This is an open-label single-arm observational trial to study the effectiveness of a commercially available meal-replacement shake and its effect on the quality of life in individuals with type 2 diabetes.
Key facts
- Study ID
- NCT05129735
- Run by
- Teatis, Inc
- People needed
- 0
- Starts
- 2022-09-15
- Expected to finish
- 2022-12-30
- Last updated by the study team
- 2024-08-23
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or Female between 18-75 years old
- Diagnosed with type 2 diabetes for at least 3 months
- HbA1c of 7.5 to 10% inclusive
- BMI of 27 to 40 kg/m2
- If on any medication, treated with a stable dose for at least 90 days
- Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- Willing and able to provide written informed consent
- Must have a Glucometer at home
You may not qualify if…
- Diagnosis of type 1 diabetes
- Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization within the prior 6 months
- Use of dietary supplements or meal-replacement shakes targeted at diabetes and unwilling to stop using them for the duration of the study
- Allergies to any test product ingredients
- Has any of the following medical conditions:
- Oncological conditions
- Psychiatric disease
- Cardiovascular disease: any hospitalization within the past 3 months
- Multiple Sclerosis
- Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.
- Any other severe chronic disease
- History of drug or alcohol abuse
- Females who are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding during the course of the study
- Participation in a clinical research trial within 30 days prior to screening
- Participating in an investigational health product research study
- Any disorder, unwillingness, or inability, which in the investigator's opinion, might jeopardize the individual's safety or compliance with the protocol
Where it is running
- Citruslabs — Santa Monica, California, United States
Full record on ClinicalTrials.gov
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