NCT00525694

Brief Summary

This will be a clinical test to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus. This research trial will evaluate the effect of three different solutions on blood glucose level. One solution is plain water, the second a standard high glucose (sugar) solution used typically in diabetes testing, and the third a low calorie drink (Zero Coke). Based on a prior study evaluating a diet for effective weight loss, we observed that patients who drank large volumes of diet soda did not lose weight as readily as those who did not drink diet soda. Therefore, we propose to examine the actual effect of one diet soda (Zero Coke) on the body's glucose level and compare it to water and a high glucose solution. All participants in this study must have 3 Glucose tolerance evaluations - one with each solution: water, high glucose, and Zero Coke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

3.8 years

First QC Date

September 5, 2007

Last Update Submit

July 7, 2016

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • to determine if any carbohydrate or a gluconeogenic precursor added to a zero calorie product might be important to consider in the management of obesity, metabolic syndrome and diabetes mellitus.

    3 days

Study Arms (3)

1

OTHER

glucose tolerance test solution

Other: Glucose tolerance testOther: glucose tolerance test solution

2

OTHER

Diet Coke

Other: Diet Coke

3.

OTHER

Coke Zero

Other: Coke Zero

Interventions

Glucose tolerance testOTHER

10 ounces glucose tolerance test solution

1
glucose tolerance test solutionOTHER

75 grams glucose load

1
Diet CokeOTHER

10 ounces of Diet Coke

2
Coke ZeroOTHER

10 ounces of Coke Zero

3.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy,
  • asymptomatic individuals for diabetes and pre-diabetes,
  • especially for people at high risk of developing diabetes,
  • such as those with a family history of diabetes,
  • those who are overweight,
  • and those who are more than 40 to 45 years old

You may not qualify if:

  • Patients with chronic illnesses, especially diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19718, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • James Hays, MD

    Christiana Care Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2007

First Posted

September 6, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations

US(1)