Status:
COMPLETED
GOLO Open-Label Pilot 1
Lead Sponsor:
Golo
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
18-69 years
Phase:
NA
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 populatio...
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. GF...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2017
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03478202
Start Date
August 1 2017
End Date
December 23 2017
Last Update
March 27 2018
Active Locations (1)
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1
Buynak Clinical Research
Valparaiso, Indiana, United States, 46385