Clinical trial NCT01554020: Blood Sugar Take Care and Glucose Metabolism
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Prediabetes
Keywords: Blood glucose
Insulin sensitivity
Oral glucose tolerance
Lead sponsor: NewChapter, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2012-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: SUBJECT INCLUSION CRITERIA: STEP 1

1. Age ≥ 18 years
2. Subject meets American Diabetes Association criteria for diabetes testing in asymptomatic, undiagnosed individuals:

   1. If age ≥45 years, subject must have a body mass index ≥ 25 kg/m2 for United States and ≥ 24 kg/m2 for Indonesia
   2. 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
3. Stable body weight (\<5% change) in the last 3 months
4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
5. Able to understand the nature and purpose of the study including potential risks and side effects
6. Willing to consent to study participation and to comply with study requirements

SUBJECT EXCLUSION CRITERIA

1. Known diabetes (type I or II)
2. 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
3. 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
4. Daily use of nonsteroidal anti-inflammatory drugs (NSAIDS); (daily baby aspirin use acceptable)
5. 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
6. Anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction
7. Eating disorder
8. Polycystic ovary syndrome
9. Known allergies to any substance in the study product
10. Pregnant or breastfeeding women
11. History of alcohol, drug, or medication abuse
12. Participation in another study with any investigational product within 3 months of screening
13. Recent (\<3 months) gastrointestinal surgery or any planned surgery during the treatment period

SUBJECT INCLUSION CRITERIA: STEP 2

1. Fasting glucose between 95 and 130 mg/dl, based on portable glucometer reading

SUBJECT INCLUSION CRITERIA: STEP 3

1. Impaired fasting glucose, based on the American Diabetes Association definition of fasting serum glucose between 100 and 125 mg/dl
2. 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

Primary outcomes:
measure: Fasting glucose
timeFrame: 12 weeks
Secondary outcomes:
measure: Insulin sensitivity index
timeFrame: 12 weeks
measure: Fasting insulin
timeFrame: 12 weeks
measure: Homeostasis Model Assessment of Insulin Resistance
timeFrame: 12 weeks
measure: Quantitative insulin sensitivity check index
timeFrame: 12 weeks
measure: Insulin secretion/insulin resistance index
timeFrame: 12 weeks
measure: Glycosylated hemoglobin (HbA1c)
timeFrame: 12 weeks
measure: High-sensitivity C-reactive protein
timeFrame: 12 weeks
measure: High-molecular weight adiponectin
timeFrame: 12 weeks
measure: Lipids (total cholesterol, HDL, LDL, VLDL, triglycerides)
timeFrame: 12 weeks
measure: Body composition
timeFrame: 12 weeks
measure: WHO Quality of Life Questionnaire
timeFrame: 12 weeks
measure: Comprehensive metabolic panel
timeFrame: 12 weeks
measure: Complete blood count
timeFrame: 12 weeks
measure: Adverse events
timeFrame: 12 weeks
measure: Gastrointestinal Symptom Rating Scale
timeFrame: 12 weeks
measure: Pulse
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: SPRIM
state: California
Study officials:
affiliation: Sprim Advanced Life Sciences
name: Larry Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References: