GOLO Open-Label Pilot 1

NCT03478202 | Completed

• 1 other identifier: GOLO1701
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type II

Outcome Measures

Primary Outcomes (1)

• Change from baseline in weight

  3 months

Secondary Outcomes (5)

• 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

Study Arms (1)

Open Label RELEASE Supplement

EXPERIMENTAL

Dietary Supplement: GOLO RELEASE

Interventions

GOLO RELEASE DIETARY_SUPPLEMENT

GOLO RELEASE plus Diet

Open Label RELEASE Supplement

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Golo: lead

Study Sites (1)

Buynak Clinical Research

Valparaiso, Indiana, 46385, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: March 27, 2018
• Study Start: August 1, 2017
• Primary Completion: December 23, 2017
• Study Completion: December 23, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

US (1)