Status:
UNKNOWN
Effects of the GOLO for Life System Diet With and Without GOLO Release Supplement on Glycemic Control and Insulin Resistance
Lead Sponsor:
Golo
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
NA
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 meta...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2020
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04082390
Start Date
October 1 2019
End Date
January 31 2020
Last Update
September 9 2019
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