GOLO Open-Label Pilot 1
Status: | Completed |
---|---|
Conditions: | Diabetes, Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - 69 |
Updated: | 4/17/2018 |
Start Date: | August 1, 2017 |
End Date: | December 23, 2017 |
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.
available GOLO for Life (GFL) weight management program on body weight in a type 2 diabetic
patient population after approximately 3 months.
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.
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.
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
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