Diabetes Mellitus, Type IINCT03478202
GOLO Open-Label Pilot 1
A study testing GOLO RELEASE in people with Diabetes Mellitus, Type II, run by Golo at 1 site in United States.
Trial summary
The objective of this open-label pilot study is to evaluate the effect of the commercially available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic patient population after approximately 3 months. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- GOLO RELEASE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 23 Dec 2017
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 69 years
- Diagnosis of type 2 diabetes mellitus at least six months prior to enrollment
- Currently being treated for type 2 diabetes mellitus with oral medication or diet therapy
- Oral medications or diet therapy for diabetes stable for at least three months prior to enrollment
- Body mass index (BMI) ≥ 30 and ≤ 45 kg/m2
- Have the ability to engage in at least 15 minutes of moderate physical activity such as brisk walking
- Willing to comply with study procedures described herein
Who cannot join
- Current uncontrolled type 2 diabetes (clinically significant increases in FBG or HbA1c in the past 6 months, as determined by a physician or other appropriate clinical measure)
- 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 GOLO for Life supplement
- A history of prior surgery for weight loss
- Currently taking injectable medications to control diabetes, including insulin and GLP-1 agonists
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- Current diagnosis with Type 1 diabetes mellitus
- 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).
- Clinically unstable heart disease or uncontrolled hypertension at screening defined as Systolic blood pressure greater than 180 mmHG or Diastolic blood pressure greater than 100 mmHG
- Current clinical diagnosis of unstable or uncontrolled kidney or liver disease, cancer, 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
1 site in 1 country.
About this study
Official title: An Open-Label Pilot Study Evaluating the Effect of the GOLO for Life Weight Management Program on Weight and Metabolic Syndrome Indicators in Patients With Type II Diabetes Mellitus
The objective of this open-label pilot study is to evaluate the effect of the commercially available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic patient population after approximately 3 months.
Read the detailed description
Golo For Life (GFL) is a weight management program that helps people who are overweight or obese limit and portion their consumption of conventional foods and make healthier choices in their diets. GFL includes a point-based system from the four macronutrient food groups that is based on the individual's activity level and body mass. Additionally, GFL includes common-sense instructions, motivation and tips supporting compliance and requires a minimum of 15 minutes of exercise per day. GFL also includes a dietary supplement containing zinc and chromium, essential nutrients that support regulation of blood sugar.
In case studies from clinician and wellness program use, GFL has shown the ability to reduce body weight in both healthy and diabetic people who are overweight or obese. Secondary endpoints including measures of blood sugar have been observed to decrease as a result of the GFL program.
While GFL has been developed and used in private clinical practice in both healthy overweight and type 2 diabetic people, more systematic research is needed to determine to what extent it is able to support healthy weight loss. This open-label pilot study is intended to observe the effects of the program in a representative group of subjects with stable type 2 diabetes at one outpatient medical practice.
The objective of this open-label pilot study is to evaluate the effect of the commercially available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic patient population after approximately 3 months.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- GOLO RELEASE
- 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.
GOLO RELEASEDietary supplement
GOLO RELEASE plus Diet
| Study group | Role | What they receive |
|---|---|---|
| Open Label RELEASE Supplement | Experimental | Not described Receives: Dietary Supplement: GOLO RELEASE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in weight
Measured: 3 months
Secondary outcomes (5)
Change from baseline in waist circumference
Measured: 3 months
Change from baseline in hip circumference
Measured: 3 months
Change from baseline in Body Mass Index (BMI)
Measured: 3 months
Change from baseline in Hemoglobin A1C
Measured: 3 months
Change from baseline in fasting Insulin level
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start1 Aug 2017
- Primary completion23 Dec 2017
- Study completion23 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478202
- Sponsor's protocol ID
- GOLO1701
- Status last verified
- Mar 2018
- First submitted
- 19 Mar 2018
- Last updated
- 27 Mar 2018
- 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 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Pilot Study Evaluating the Effect of the GOLO for Life Weight Management Program on Weight and Metabolic Syndrome Indicators in Patients With Type II Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03478202
- Acronym / sponsor ID
- GOLO1701
- Conditions
- Diabetes Mellitus, Type II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GoloIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 23 Dec 2017 (actual)
- Study completion
- 23 Dec 2017 (actual)
- First posted
- 27 Mar 2018 (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.
The objective of this open-label pilot study is to evaluate the effect of the commercially available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic patient population after approximately 3 months.
Detailed description
Golo For Life (GFL) is a weight management program that helps people who are overweight or obese limit and portion their consumption of conventional foods and make healthier choices in their diets. GFL includes a point-based system from the four macronutrient food groups that is based on the individual's activity level and body mass. Additionally, GFL includes common-sense instructions, motivation and tips supporting compliance and requires a minimum of 15 minutes of exercise per day. GFL also includes a dietary supplement containing zinc and chromium, essential nutrients that support regulation of blood sugar.
In case studies from clinician and wellness program use, GFL has shown the ability to reduce body weight in both healthy and diabetic people who are overweight or obese. Secondary endpoints including measures of blood sugar have been observed to decrease as a result of the GFL program.
While GFL has been developed and used in private clinical practice in both healthy overweight and type 2 diabetic people, more systematic research is needed to determine to what extent it is able to support healthy weight loss. This open-label pilot study is intended to observe the effects of the program in a representative group of subjects with stable type 2 diabetes at one outpatient medical practice.
The objective of this open-label pilot study is to evaluate the effect of the commercially available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic patient population after approximately 3 months.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label RELEASE Supplement | Experimental | Dietary Supplement: GOLO RELEASE |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and ≤ 69 years
- Diagnosis of type 2 diabetes mellitus at least six months prior to enrollment
- Currently being treated for type 2 diabetes mellitus with oral medication or diet therapy
- Oral medications or diet therapy for diabetes stable for at least three months prior to enrollment
- Body mass index (BMI) ≥ 30 and ≤ 45 kg/m2
Key exclusion criteria (14 listed)
- Current uncontrolled type 2 diabetes (clinically significant increases in FBG or HbA1c in the past 6 months, as determined by a physician or other appropriate clinical measure)
- 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 GOLO for Life supplement
- A history of prior surgery for weight loss
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 |
|---|---|---|
| GOLO RELEASEGOLO RELEASE plus Diet | Dietary supplement | Open Label RELEASE Supplement |
Primary outcome
Change from baseline in weight
Time frame: 3 months
5 secondary outcomes
Change from baseline in waist circumference
Time frame: 3 months
Change from baseline in hip circumference
Time frame: 3 months
Change from baseline in Body Mass Index (BMI)
Time frame: 3 months
Change from baseline in Hemoglobin A1C
Time frame: 3 months
Change from baseline in fasting Insulin level
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GOLO RELEASE in people with Diabetes Mellitus, Type II, run by Golo at 1 site in United States.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 27 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weight (time frame: 3 months). 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 27 Mar 2018.