NCT01468376

Brief Summary

The purpose of this study is to determine a safe,tolerable and efficacious dose of GLU-xx.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

November 7, 2011

Last Update Submit

January 26, 2012

Conditions

Impaired Glucose Tolerance

Keywords

impaired glucose tolerancepre-diabetes

Outcome Measures

Primary Outcomes (1)

  • Glucose and insulin response to the Oral Glucose Tolerance Test after administration of GLU-xx formulations

    14 days

Secondary Outcomes (1)

  • Safety and tolerability of GLU-xx formulations

    14 Days

Study Arms (6)

GLU-01

EXPERIMENTAL
Dietary Supplement: GLU-01

GLU-02

EXPERIMENTAL
Dietary Supplement: GLU-02

GLU-03

EXPERIMENTAL
Dietary Supplement: GLU-03

GLU-04

EXPERIMENTAL
Dietary Supplement: GLU-04

GLU-05

EXPERIMENTAL
Dietary Supplement: GLU-05

GLU-06

EXPERIMENTAL
Dietary Supplement: GLU-06

Interventions

GLU-01DIETARY_SUPPLEMENT

14 day dosing

GLU-01
GLU-02DIETARY_SUPPLEMENT

14 day dosing

GLU-02
GLU-03DIETARY_SUPPLEMENT

14 day dosing

GLU-03
GLU-04DIETARY_SUPPLEMENT

14 day dosing

GLU-04
GLU-05DIETARY_SUPPLEMENT

14 day dosing

GLU-05
GLU-06DIETARY_SUPPLEMENT

14 day dosing

GLU-06

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Generally healthy adults between 21-65 years of age
  • Body Mass Index (BMI) between 25 and ≤40
  • OGTT (75g glucola) peak value between ≥140mg/dl and ≤199 mg/dl at screening visit
  • Willingness to adhere to the requirements of the protocol, including availability for follow-up visits and donation of blood samples
  • Willingness and ability to sign written informed consent
  • Women of child bearing capacity who agree to use an acceptable form of birth control during the trial \[i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD or tubal ligation\]

You may not qualify if:

  • Active diabetes mellitus \[fasting blood glucose of ≥7.0 mmol/L (≥126 mg/dL) or ≥11.1 mmol/L (≥200 mg/dL) after OGTT\]
  • Current coronary artery/ cardiovascular disease or history of a cardiovascular event (stroke, transient ischemic attack, myocardial infarction, angioplasty or coronary artery bypass grafting, angina pectoris) or have undergone a cardiovascular intervention within the past three months
  • Seizure disorder
  • Blood disorders, including anemia (i.e., hemoglobin levels less than 13 g/dL in men and less than 12 g/dL in women)
  • Active infection, including HIV, hepatitis, etc
  • Participants on Estrogen replacement must be on a stable dose for at least 3 months
  • Serious illness requiring ongoing medical care or medication
  • Gastrointestinal disorders or prior gastrointestinal surgeries (including gastric bypass or lap-band) that might cause complications or influence motility or satiety (e.g.,diverticulitis, inflammatory bowel disease, irritable bowel syndrome, intestinal narrowing or obstruction, difficulty swallowing)
  • Any congenital spinal cord deformities or traumatic spinal cord injuries
  • Uncorrected hypothyroidism
  • Other significant metabolic endocrine disease
  • Active liver disease or liver function impairment as evidenced by a history of liver disease or liver enzyme elevations \>three times the upper limit of normal
  • Current cancer
  • Significant kidney disease (calculated by eGFR \<60 mL/min)
  • History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, neurological,or psychiatric disorders which in the opinion of the investigator would be expected to interfere with the study or increase risk to the subject
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Staywell Research LLC

Northridge, California, 91325, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Jay Udani, MD

    Medicus Research LLC/Staywell Research LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 9, 2011

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)