Effects of the GOLO for Life System Diet With and Without GOLO Release Supplement on Glycemic Control and Insulin Resistance

Golo

Status

Unknown

Conditions

Diabetes Mellitus, Type 2

Treatments

Dietary Supplement: Placebo

Dietary Supplement: RELEASE

Study type

Interventional

Funder types

Industry

Identifiers

NCT04082390

GOLO 1704

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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