Diabetes Mellitus, Type 2NCT04082390
Effects of the GOLO for Life System Diet With and Without GOLO Release Supplement on Glycemic Control and Insulin Resistance
A study testing RELEASE in people with Diabetes Mellitus, Type 2, run by Golo.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- RELEASE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- RELEASE, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELEASEDietary supplement
Dietary supplement
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| RELEASE Supplement | Experimental | Not described Receives: Dietary Supplement: RELEASE |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (10)
Change from baseline in Fructosamine between the 2 groups
Measured: 4 weeks
Change from baseline in HGB A1C between the 2 groups
Measured: 4 weeks
Change from baseline in Insulin Levels between the 2 groups
Measured: 4 weeks
Change from baseline in HOMA-IR between the 2 groups
Measured: 4 weeks
Change from baseline in Weight between the 2 groups
Measured: 4 weeks
Change from baseline in Body Mass Index between the 2 groups
Measured: 4 weeks
Change from baseline in Hip Circumference between the 2 groups
Measured: 4 weeks
Change from baseline in Waist Circumference between the 2 groups
Measured: 4 weeks
Change from baseline in Blood Pressure between the 2 groups
Measured: 4 weeks
Change from baseline in Heart Rate between the 2 groups
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion30 Jan 2020 (estimated)
- Study completion31 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Golo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082390
- Sponsor's protocol ID
- GOLO 1704
- Status last verified
- Sep 2019
- First submitted
- 4 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04082390
- Acronym / sponsor ID
- GOLO 1704
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- GoloIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 30 Jan 2020 (estimated)
- Study completion
- 31 Jan 2020 (estimated)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RELEASE Supplement | Experimental | Dietary Supplement: RELEASE |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELEASEDietary supplement | Dietary supplement | RELEASE Supplement |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
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
10 secondary outcomes
Change from baseline in Fructosamine between the 2 groups
Time frame: 4 weeks
Change from baseline in HGB A1C between the 2 groups
Time frame: 4 weeks
Change from baseline in Insulin Levels between the 2 groups
Time frame: 4 weeks
Change from baseline in HOMA-IR between the 2 groups
Time frame: 4 weeks
Change from baseline in Weight between the 2 groups
Time frame: 4 weeks
Change from baseline in Body Mass Index between the 2 groups
Time frame: 4 weeks
Change from baseline in Hip Circumference between the 2 groups
Time frame: 4 weeks
Change from baseline in Waist Circumference between the 2 groups
Time frame: 4 weeks
Change from baseline in Blood Pressure between the 2 groups
Time frame: 4 weeks
Change from baseline in Heart Rate between the 2 groups
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing RELEASE in people with Diabetes Mellitus, Type 2, run by Golo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Buynak, MD (2194648302, RBUYNAK@ATT.NET), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.