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

NCT04082390 | Unknown

• 1 other identifier: GOLO 1704
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change from baseline in Fructosamine between the 2 groups

  4 weeks

• 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

Study Arms (2)

RELEASE Supplement

EXPERIMENTAL

Dietary Supplement: RELEASE

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

RELEASE DIETARY_SUPPLEMENT

Dietary supplement

RELEASE Supplement

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Golo: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Drainage

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Robert Buynak, MD

CONTACT

2194648302; RBUYNAK@ATT.NET

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 9, 2019
• Study Start: October 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 31, 2020
• Last Updated: September 9, 2019

Record last verified: 2019-09