GOLO Open-Label Pilot 1

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type II

Intervention / Treatment
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* Dietary Supplement: GOLO RELEASE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label RELEASE Supplement<br> | Dietary Supplement: GOLO RELEASE<br>* GOLO RELEASE plus Diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in weight |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in waist circumference |  | 3 months | 
| Change from baseline in hip circumference |  | 3 months | 
| Change from baseline in Body Mass Index (BMI) |  | 3 months | 
| Change from baseline in Hemoglobin A1C |  | 3 months | 
| Change from baseline in fasting Insulin level |  | 3 months |