Diabetes Mellitus, Type 2
Conditions
Brief summary
This randomized, double-blind placebo-controlled study is intended to observe the short-term effects of the GFL System Diet with Release supplement versus GFL System Diet with placebo on glycemic metabolism and insulin resistance in patients with Type 2 DM.
Interventions
DIETARY_SUPPLEMENTRELEASE
Dietary supplement
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Golo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years and ≤ 80 years * Body mass index (BMI) ≥ 27 and ≤ 60 kg/m2 * Have the ability to engage in at least 15 minutes of moderate physical activity such as brisk walking * A1C greater than or equal to 6.5% at screening * Willing to comply with study procedures described herein
Exclusion criteria
* Current diagnosis of type 1 diabetes * Subjects with a history of hypoglycemia * A history of an eating disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) * Known allergy to any of the components in the Release supplement * A history of prior surgery for weight loss within one year from screening * Currently taking injectable medications to control diabetes, including insulin and GLP-1 agonists * Currently pregnant or breastfeeding or have had a baby within the last six weeks * Planning to become pregnant in the next three months. Women of child-bearing potential must be willing and able to use adequate and reliable contraception throughout the study (e.g. abstinence or barrier with additional spermicidal foam or jelly, or the use of intrauterine device or hormonal contraception). * Uncontrolled hypertension at screening defined as Systolic blood pressure greater than 180 mmHG or Diastolic blood pressure greater than 110 mmHG * Current clinical diagnosis or signs and symptoms of unstable (in the opinion of the principle investigator) heart, kidney or liver disease, cancer, or chronic neurological disease. * Current participation in any other weight loss or weight management program * Currently taking weight loss medications, or medications or supplements known to be associated with significant weight loss or weight gain * Has any condition that, in the opinion of the investigator, would make participation in this study not in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments. Examples include: history of diabetic ketoacidosis; active chronic liver disease or cirrhosis; chronic autoimmune disease; inflammatory bowel disease, colonic ulceration, partial intestinal obstruction, subjects predisposed to intestinal obstruction; chronic intestinal diseases associated with marked disorders of digestion or absorption
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Fasting Blood Glucose (FBG) at approximately 4 weeks of the GFL System Diet with Release supplement versus GFL System Diet with placebo supplement | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HGB A1C between the 2 groups | 4 weeks |
| Change from baseline in Insulin Levels between the 2 groups | 4 weeks |
| Change from baseline in HOMA-IR between the 2 groups | 4 weeks |
| Change from baseline in Weight between the 2 groups | 4 weeks |
| Change from baseline in Fructosamine between the 2 groups | 4 weeks |
| Change from baseline in Hip Circumference between the 2 groups | 4 weeks |
| Change from baseline in Waist Circumference between the 2 groups | 4 weeks |
| Change from baseline in Blood Pressure between the 2 groups | 4 weeks |
| Change from baseline in Heart Rate between the 2 groups | 4 weeks |
| Change from baseline in Body Mass Index between the 2 groups | 4 weeks |
Contacts
Primary ContactRobert Buynak, MD
Outcome results
None listed