NCT01554020WithdrawnPhase 2
Effect of Blood Sugar Take Care on Glucose Metabolism, Determinants of Metabolic Syndrome, and Quality of Life in Prediabetic Adults: A Randomized, Double-blind, Placebo-controlled Study
NewChapter, Inc.2 sites in 1 countryStarted: June 1, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Locations
- 2
- Primary Endpoint
- Fasting glucose
Study Overview
Brief Summary
This prospective international clinical trial is a two-arm, double-blind, randomized, placebo-controlled, parallel-group, multicenter study. 112 prediabetic subjects will be randomized to Blood Sugar Take Care or placebo. Randomization will be stratified by gender. The intervention period is 12 weeks. The primary outcome is fasting glucose levels.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •SUBJECT INCLUSION CRITERIA: STEP 1
- •Age ≥ 18 years
- •Subject meets American Diabetes Association criteria for diabetes testing in asymptomatic, undiagnosed individuals:
- •If age ≥45 years, subject must have a body mass index ≥ 25 kg/m2 for United States and ≥ 24 kg/m2 for Indonesia
- •If age <45 years, subject must have a body mass index ≥ 25 kg/m2 for United States and ≥ 24 kg/m2 for Indonesia AND present with at least one of the following risk factors:
- •Have a first-degree relative with diabetes
- •Habitually physically inactive
- •Race is African-American, Hispanic American, Native American, Asian American, or Pacific Islander
- •Have delivered a baby weighing >9 lb or have been diagnosed with gestational diabetes mellitus
- •Hypertensive (≥140/90)
- •Known HDL cholesterol level 35 mg/dl
- •Known triglyceride level ≥250 mg/dl
- •On previous testing, had impaired glucose tolerance or impaired fasting glucose
- •History of vascular disease
- •Stable body weight (<5% change) in the last 3 months
- •Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
- •Able to understand the nature and purpose of the study including potential risks and side effects
- •Willing to consent to study participation and to comply with study requirements
Exclusion Criteria
- •Known diabetes (type I or II)
- •Recent use (within 2 weeks of screening) of any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose or lipid metabolism
- •Recent use (within 4 weeks of screening) of any prescription or OTC medication that significantly affects glucose or lipid metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, DPP-4 inhibitors, systemic corticosteroids, statins, fibrates, niacin, and bile acid sequestrants
- •Daily use of nonsteroidal anti-inflammatory drugs (NSAIDS); (daily baby aspirin use acceptable)
- •Any comorbidity that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes
- •Anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction
- •Eating disorder
- •Polycystic ovary syndrome
- •Known allergies to any substance in the study product
- •Pregnant or breastfeeding women
- •History of alcohol, drug, or medication abuse
- •Participation in another study with any investigational product within 3 months of screening
- •Recent (<3 months) gastrointestinal surgery or any planned surgery during the treatment period
- •SUBJECT INCLUSION CRITERIA: STEP 2
- •Fasting glucose between 95 and 130 mg/dl, based on portable glucometer reading
- •SUBJECT INCLUSION CRITERIA: STEP 3
- •Impaired fasting glucose, based on the American Diabetes Association definition of fasting serum glucose between 100 and 125 mg/dl
- •Impaired glucose tolerance, based on the American Diabetes Association definition of serum glucose between 140 and 199 mg/dl 2 hours after a 75 g glucose load
Outcomes
Primary Outcomes
Fasting glucose
Time Frame: 12 weeks
Secondary Outcomes
- Insulin sensitivity index(12 weeks)
- Fasting insulin(12 weeks)
- Homeostasis Model Assessment of Insulin Resistance(12 weeks)
- Quantitative insulin sensitivity check index(12 weeks)
- Insulin secretion/insulin resistance index(12 weeks)
- Glycosylated hemoglobin (HbA1c)(12 weeks)
- High-sensitivity C-reactive protein(12 weeks)
- High-molecular weight adiponectin(12 weeks)
- Lipids (total cholesterol, HDL, LDL, VLDL, triglycerides)(12 weeks)
- Body composition(12 weeks)
- WHO Quality of Life Questionnaire(12 weeks)
- Comprehensive metabolic panel(12 weeks)
- Complete blood count(12 weeks)
- Adverse events(12 weeks)
- Gastrointestinal Symptom Rating Scale(12 weeks)
- Pulse(12 weeks)
- Blood pressure(12 weeks)
Investigators
Study Sites (2)
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