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Dietary Supplement
GOLO for Life® Plan + Release for Type 2 Diabetes and Obesity
Phase 2
Recruiting
Led By David Crowley, MD
Research Sponsored by Golo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, day 90, day 180
Awards & highlights
Study Summary
This trial is studying the effect of a diet & supplement plan on weight & glycemic control for those with Type 2 Diabetes. Safety & tolerability of the plan will be measured.
Who is the study for?
Adults aged 18-65 with Type 2 Diabetes, HbA1c levels between ≥6.5% to <9%, and a BMI of 25-39.9 kg/m2 can join this trial. They must have stable diabetes medication for the past three months, not be pregnant or planning pregnancy, maintain current lifestyle habits, and agree to use birth control if applicable.Check my eligibility
What is being tested?
The GOLO for Life Plan with Release supplement is being tested for its effectiveness on blood sugar control and weight loss in overweight adults with Type 2 Diabetes over a period of up to six months.See study design
What are the potential side effects?
Possible side effects include reactions related to ingredients in the Release supplement or changes due to diet adjustments. Specific side effects will be monitored through reports of any adverse events during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, day 90, day 180
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, day 90, day 180
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The change in glycemic control as measured by HOMA-IR from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
The change in glycemic control as measured by HbA1c from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
The change in glycemic control as measured by change in weight (kilograms) from baseline at Days 90 and 180 following the G4LP and supplementation with Release.
+3 moreSecondary outcome measures
The change in arm circumference from baseline at days 90 and 180 following the G4LP and supplementation with Release.
The change in blood pressure from baseline at days 90 and 180 following the G4LP and supplementation with Release.
The change in body mass index (BMI) from baseline at days 90 and 180 following the G4LP and supplementation with Release.
+8 moreOther outcome measures
Clinically relevant changes in alanine aminotransferase (ALT) after 180 days.
Clinically relevant changes in alkaline phosphatase (ALP) after 180 days.
Clinically relevant changes in aspartate aminotransferase (AST) after 180 days.
+17 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: GOLO for Life® Plan (G4LP) and Release SupplementExperimental Treatment1 Intervention
Participants will be instructed to use the resources provided and follow the G4LP for the duration of the study period. Participants will also take one capsule of Release three times a day, to be taken at the beginning of or during each meal, starting on Day 1. If a dose is missed before or during a meal, participants are instructed to take the dose as soon as they remember after the meal. Participants will be advised not to exceed three capsules daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Release
2023
Completed Phase 2
~90
Find a Location
Who is running the clinical trial?
GoloLead Sponsor
4 Previous Clinical Trials
214 Total Patients Enrolled
1 Trials studying Obesity
68 Patients Enrolled for Obesity
KGK Science Inc.Industry Sponsor
78 Previous Clinical Trials
6,060 Total Patients Enrolled
2 Trials studying Obesity
109 Patients Enrolled for Obesity
David Crowley, MDPrincipal InvestigatorKGK Science Inc.
35 Previous Clinical Trials
2,653 Total Patients Enrolled
1 Trials studying Obesity
95 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am taking medications or supplements that could affect my blood sugar, weight, or metabolism.I haven't had major surgery in the last 3 months and don't plan any during the study.I have had surgery to help me lose weight.My kidneys and liver are currently stable, except I may have had kidney stones but have been symptom-free for 6 months.I have Type 1 diabetes.My cancer, except for fully treated skin cancer, has been in remission for over 5 years.I have had a gout flare-up within the last year.I am between 18 and 75 years old.I have type 2 diabetes and am being treated with insulin.I have a thyroid condition and have been on a stable medication dose for 3+ months.I agree to keep my lifestyle, medication, and sleep habits the same during the study.I have or had serious stomach or intestine problems.I am able to understand and agree to the study's procedures and risks.I am a woman who cannot become pregnant due to sterilization or being post-menopausal for over a year.I use cannabis more than once a month or will stop using it for the study.My HbA1c level is 6.0% or higher, and my diabetes medication hasn't changed in the last 3 months.I have not donated blood within 30 days before the study and will not during or within 30 days after.
Research Study Groups:
This trial has the following groups:- Group 1: GOLO for Life® Plan (G4LP) and Release Supplement
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the GOLO for Life® Plan (G4LP) and Release Supplement been granted regulatory approval by the FDA?
"We have assessed the safety of GOLO for Life® Plan (G4LP) and Release Supplement to be a 2 on a scale from 1-3. This is due to existing evidence that supports its security, although there are no studies confirming efficacy."
Answered by AI
May I be eligible to participate in this research?
"In order to be eligible, participants must possess a BMI above the healthy range and fall between 18-65 years old. The maximum capacity for this trial is 100 applicants."
Answered by AI
Are there any available opportunities for participants in this experiment?
"Affirmative. Clinicaltrials.gov's findings reveal that this research is actively seeking participants, which was posted on April 20th of 2021 and most recently updated on the 25th of the same month. The scope entails recruiting 100 patients from 2 different medical centres."
Answered by AI
Is the eligibility for this trial confined to individuals aged 18 or above?
"This research study is looking for individuals that have reached the legal age of consent and are below 65 years old. For those under 18, there are 250 studies available while 1,304 trials cover seniors over 65 years of age."
Answered by AI
How many participants are currently engaged in this clinical trial?
"Indeed, the information available on clinicaltrials.gov states that this research endeavour is actively seeking participants. It was initially posted on April 20th of 2021 and last edited four days later; it requires 100 individuals from two locations for completion."
Answered by AI
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