NCT01846767

Brief Summary

The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in type 2 diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable diabetes-mellitus-type-2

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

April 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

May 1, 2013

Last Update Submit

November 25, 2014

Conditions

Diabetes Mellitus, Type 2

Keywords

13CO2Breath testGlucose oxidationDiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Peak Delta over baseline in 13CO2 breath enrichment

    The peak enrichment of 13CO2 in breath is calculated by identifying the highest abundance breath sample and subtracting the base line abundance from it.

    at 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes after glucose ingestion.

Secondary Outcomes (1)

  • Per cent dose recovered

    240 minutes

Other Outcomes (1)

  • Diabetes classifications and measures of insulin resistance

    0 and 120 minutes

Study Arms (2)

Type 2 diabetes

EXPERIMENTAL

Diabetic patients Oral glucose breath test

Other: Oral glucose breath test

Healthy controls

EXPERIMENTAL

non-diabetic Oral glucose breath test

Other: Oral glucose breath test

Interventions

Oral glucose breath testOTHER

Simultaneous oral glucose tolerance test and exogenous 13C-glucose breath test following a 12hr overnight fast. Fasting samples were obtained for plasma glucose, insulin, c-peptide, leptin, adiponectin, resistin, HbA1c and two breath 13CO2 abundance values (at t = -15 and -5min). At t = 0min, each subject drank a 75g glucose solution (Thornton \& Ross, UK) containing 0.15g of 1-13C glucose. Further breath samples (every 15 min over a 240min interval) and further plasma blood glucose, insulin and c-peptide samples (90,120,180min) were also taken.

Healthy controlsType 2 diabetes

Eligibility Criteria

Age35 Years - 82 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All research participants must be between 18 and 65 years
  • Non-diabetic participants must not be taking any medication for diabetes
  • Participants must speak English or Irish proficiently
  • All participants must be males
  • All participants must live within Galway City
  • Type 2 diabetic participants must have been diagnosed within the last five years
  • Type 2 diabetic participants must be treated by Metformin alone for their diabetes
  • All participants must provide written informed consent to comply with every aspect of the study

You may not qualify if:

  • Females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiology laboratory

Galway, Galway, 11111, Ireland

Location

Related Publications (5)

  • Rating D, Langhans CD. Breath tests: concepts, applications and limitations. Eur J Pediatr. 1997 Aug;156 Suppl 1:S18-23. doi: 10.1007/pl00014264.

    PMID: 9266210BACKGROUND

  • Stellaard F, Koetse HA, Elzinga H, Boverhof R, Tjoonk R, Klimp A, Vegter D, Liesker J, Vonk RJ. 13C-carbohydrate breath tests: impact of physical activity on the rate-limiting step in lactose utilization. Scand J Gastroenterol. 2000 Aug;35(8):819-23. doi: 10.1080/003655200750023183.

    PMID: 10994620BACKGROUND

  • Lifschitz CH, Boutton TW, Carrazza F, Beyreiss K, Schmitz J, Ricour C, Shulman R, Nichols BL. A carbon-13 breath test to characterize glucose absorption and utilization in children. J Pediatr Gastroenterol Nutr. 1988 Nov-Dec;7(6):842-7. doi: 10.1097/00005176-198811000-00008.

    PMID: 3143819BACKGROUND

  • Mizrahi M, Lalazar G, Adar T, Raz I, Ilan Y. Assessment of insulin resistance by a 13C glucose breath test: a new tool for early diagnosis and follow-up of high-risk patients. Nutr J. 2010 May 27;9:25. doi: 10.1186/1475-2891-9-25.

    PMID: 20507559BACKGROUND

  • Dillon EL, Janghorbani M, Angel JA, Casperson SL, Grady JJ, Urban RJ, Volpi E, Sheffield-Moore M. Novel noninvasive breath test method for screening individuals at risk for diabetes. Diabetes Care. 2009 Mar;32(3):430-5. doi: 10.2337/dc08-1578. Epub 2008 Dec 15.

    PMID: 19074994BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Amir Shafat, PhD

    National University of Ireland, Galway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 1, 2013

First Posted

May 3, 2013

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

October 1, 2014

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations

IE(1)