An Exploratory Investigation to Assess Changes in Quality of Life for Individuals With Type 2 Diabetes After Taking a Meal-replacement Shake.
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT05129735
- Lead Sponsor
- Teatis, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria:<br><br> - Male or Female between 18-75 years old<br><br> - Diagnosed with type 2 diabetes for at least 3 months<br><br> - HbA1c of 7.5 to 10% inclusive<br><br> - BMI of 27 to 40 kg/m2<br><br> - If on any medication, treated with a stable dose for at least 90 days<br><br> - Must be in good health (don't report any medical conditions asked in the screening<br> questionnaire)<br><br> - Willing and able to provide written informed consent<br><br> - Must have a Glucometer at home<br><br>Exclusion Criteria:<br><br> - Diagnosis of type 1 diabetes<br><br> - Have a history of severe hypoglycemia or hyperglycemia requiring hospitalization<br> within the prior 6 months<br><br> - Use of dietary supplements or meal-replacement shakes targeted at diabetes and<br> unwilling to stop using them for the duration of the study<br><br> - Allergies to any test product ingredients<br><br> - Has any of the following medical conditions:<br><br> - Oncological conditions<br><br> - Psychiatric disease<br><br> - Cardiovascular disease: any hospitalization within the past 3 months<br><br> - Multiple Sclerosis<br><br> - Gastrointestinal conditions such as Celiac disease, Crohn's disease, etc.<br><br> - Any other severe chronic disease<br><br> - History of drug or alcohol abuse<br><br> - Females who are pregnant, want to become pregnant for the duration of the study, or<br> who are breastfeeding during the course of the study<br><br> - Participation in a clinical research trial within 30 days prior to screening<br><br> - Participating in an investigational health product research study<br><br> - Any disorder, unwillingness, or inability, which in the investigator's opinion,<br> might jeopardize the individual's safety or compliance with the protocol
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of quality of life score from baseline to 12-weeks
- Secondary Outcome Measures
Name Time Method Improvement in a1c levels from baseline to 12-weeks;Improvement in blood glucose from baseline to 12-weeks;Improvement in insulin levels from baseline to 12-weeks;Improvement in total cholesterol levels from baseline to 12-weeks;Improvement in triglyceride levels from baseline to 12-weeks;Improvement in HDL cholesterol levels from baseline to 12-weeks;Improvement in LDL cholesterol levels from baseline to 12-weeks