Back to resultsGOLO Open-Label Pilot 1
Primary Purpose
Diabetes Mellitus, Type II
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GOLO RELEASE
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type II
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Buynak Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open Label RELEASE Supplement
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in weight
Secondary Outcome Measures
Change from baseline in waist circumference
Change from baseline in hip circumference
Change from baseline in Body Mass Index (BMI)
Change from baseline in Hemoglobin A1C
Change from baseline in fasting Insulin level
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03478202
Brief Title
GOLO Open-Label Pilot 1
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 23, 2017 (Actual)
Study Completion Date
December 23, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Golo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open Label RELEASE Supplement
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
GOLO RELEASE
Intervention Description
GOLO RELEASE plus Diet
Primary Outcome Measure Information:
Title
Change from baseline in weight
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from baseline in waist circumference
Time Frame
3 months
Title
Change from baseline in hip circumference
Time Frame
3 months
Title
Change from baseline in Body Mass Index (BMI)
Time Frame
3 months
Title
Change from baseline in Hemoglobin A1C
Time Frame
3 months
Title
Change from baseline in fasting Insulin level
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Facility Information:
Facility Name
Buynak Clinical Research
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46385
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
GOLO Open-Label Pilot 1
We'll reach out to this number within 24 hrs