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

NCT ID: NCT04082390

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-01-31

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RELEASE Supplement

Group Type: EXPERIMENTAL

RELEASE

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplement

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Interventions

RELEASE

Dietary supplement

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Golo

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Robert Buynak, MD

Role: CONTACT

RBUYNAK@ATT.NET

2194648302

Other Identifiers

GOLO 1704

Identifier Type: -

Identifier Source: org_study_id