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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

RELEASE

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RELEASE Supplement

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline in Fructosamine between the 2 groups

Change from baseline in HGB A1C between the 2 groups

Change from baseline in Insulin Levels between the 2 groups

Change from baseline in HOMA-IR between the 2 groups

Change from baseline in Weight between the 2 groups

Change from baseline in Body Mass Index between the 2 groups

Change from baseline in Hip Circumference between the 2 groups

Change from baseline in Waist Circumference between the 2 groups

Change from baseline in Blood Pressure between the 2 groups

Change from baseline in Heart Rate between the 2 groups

Full Information

NCT ID

NCT04082390

First Posted

September 4, 2019

Last Updated

September 5, 2019

Sponsor

Golo

1. Study Identification

Unique Protocol Identification Number

NCT04082390

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2019 (Anticipated)

Primary Completion Date

January 30, 2020 (Anticipated)

Study Completion Date

January 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Golo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RELEASE Supplement

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

RELEASE

Intervention Description

Dietary supplement

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in Fructosamine between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in HGB A1C between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in Insulin Levels between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in HOMA-IR between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in Weight between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in Body Mass Index between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in Hip Circumference between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in Waist Circumference between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in Blood Pressure between the 2 groups

Time Frame

4 weeks

Title

Change from baseline in Heart Rate between the 2 groups

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert Buynak, MD

Phone

2194648302

RBUYNAK@ATT.NET

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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