Effects of the GOLO for Life System Diet With and Without GOLO Release Supplement on Glycemic Control and Insulin Resistance
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ClinicalTrials.gov Identifier: NCT04082390
Recruitment Status : Unknown
Verified September 2019 by Golo. Recruitment status was: Not yet recruiting
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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effects of the GOLO for Life System Diet With and Without GOLO Release Supplement on Glycemic Control and Insulin Resistance in Overweight and Obese Subjects With Type 2 Diabetes
Estimated Study Start Date :
October 1, 2019
Estimated Primary Completion Date :
January 30, 2020
Estimated Study Completion Date :
January 31, 2020
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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