Clinical trial NCT04082390: Effects of the GOLO for Life System Diet With and Without GOLO Release Supplement on Glycemic Control and Insulin Resistance
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Golo
Sponsor class: INDUSTRY
First posted: 2019-09-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in Fructosamine between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in HGB A1C between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in Insulin Levels between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in HOMA-IR between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in Weight between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in Body Mass Index between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in Hip Circumference between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in Waist Circumference between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in Blood Pressure between the 2 groups
timeFrame: 4 weeks
measure: Change from baseline in Heart Rate between the 2 groups
timeFrame: 4 weeks
Other outcomes:
Locations:
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