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Effects of the GOLO for Life System Diet With and Without GOLO Release Supplement on Glycemic Control and Insulin Resistance

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ClinicalTrials.gov Identifier: NCT04082390
Recruitment Status : Unknown
Verified September 2019 by Golo.
Recruitment status was:  Not yet recruiting
First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Golo

Brief Summary:
This randomized, double-blind placebo-controlled study is intended to observe the short-term effects of the GFL System Diet with Release supplement versus GFL System Diet with placebo on glycemic metabolism and insulin resistance in patients with Type 2 DM.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Dietary Supplement: RELEASE Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effects of the GOLO for Life System Diet With and Without GOLO Release Supplement on Glycemic Control and Insulin Resistance in Overweight and Obese Subjects With Type 2 Diabetes
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RELEASE Supplement Dietary Supplement: RELEASE
Dietary supplement

Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo




Primary Outcome Measures :
  1. Change in Fasting Blood Glucose (FBG) at approximately 4 weeks of the GFL System Diet with Release supplement versus GFL System Diet with placebo supplement [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Fructosamine between the 2 groups [ Time Frame: 4 weeks ]
  2. Change from baseline in HGB A1C between the 2 groups [ Time Frame: 4 weeks ]
  3. Change from baseline in Insulin Levels between the 2 groups [ Time Frame: 4 weeks ]
  4. Change from baseline in HOMA-IR between the 2 groups [ Time Frame: 4 weeks ]
  5. Change from baseline in Weight between the 2 groups [ Time Frame: 4 weeks ]
  6. Change from baseline in Body Mass Index between the 2 groups [ Time Frame: 4 weeks ]
  7. Change from baseline in Hip Circumference between the 2 groups [ Time Frame: 4 weeks ]
  8. Change from baseline in Waist Circumference between the 2 groups [ Time Frame: 4 weeks ]
  9. Change from baseline in Blood Pressure between the 2 groups [ Time Frame: 4 weeks ]
  10. Change from baseline in Heart Rate between the 2 groups [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years and ≤ 80 years
  • Body mass index (BMI) ≥ 27 and ≤ 60 kg/m2
  • Have the ability to engage in at least 15 minutes of moderate physical activity such as brisk walking
  • A1C greater than or equal to 6.5% at screening
  • Willing to comply with study procedures described herein

Exclusion Criteria:

  • Current diagnosis of type 1 diabetes
  • 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 Release supplement
  • A history of prior surgery for weight loss within one year from screening
  • Currently taking injectable medications to control diabetes, including insulin and GLP-1 agonists
  • 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).
  • Uncontrolled hypertension at screening defined as Systolic blood pressure greater than 180 mmHG or Diastolic blood pressure greater than 110 mmHG
  • Current clinical diagnosis or signs and symptoms of unstable (in the opinion of the principle investigator) heart, kidney or liver disease, cancer, or 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082390


Contacts
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Contact: Robert Buynak, MD 2194648302 RBUYNAK@ATT.NET

Sponsors and Collaborators
Golo
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Responsible Party: Golo
ClinicalTrials.gov Identifier: NCT04082390    
Other Study ID Numbers: GOLO 1704
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism