NCT01826162

Brief Summary

Gut microbiota is being increasingly recognized as an important factor in fat distribution, insulin sensitivity and glucose and lipid metabolism. Accordingly, the intestinal microbiota could play an important role in the development of obesity and type 2 diabetes mellitus. The role of gut-derived short-chain fatty acids (SCFA), the formation of which is enhanced by microbial fermentation of fibre, is still controversial. At the present time, our understanding of the effects of SCFA on human metabolism (in gut or systemically) is still limited. The investigators hypothesize that the differential availability of SCFA impacts human metabolism differently. In this placebo controlled, double-blind, randomized crossover pilot study the investigators will validate in overweight/obese healthy male volunteers whether rectal administration of SCFA is a good model for studying the acute metabolic effects of SCFA. For this, it will be investigated if site of administration (in distal or proximal colon) of SCFA differentially affects parameters of substrate and energy metabolism and to test the duration of short-term effects of SCFA administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

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

Timeline
Completed

Started Apr 2013

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

February 18, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

September 15, 2015

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

February 18, 2013

Last Update Submit

September 14, 2015

Conditions

Type 2 Diabetes MellitusObesity

Outcome Measures

Primary Outcomes (1)

  • Fat oxidation, energy expenditure

    Fat oxidation and energy expenditure are measured during fasting acetate/placebo infusion and during acetate/placebo infusion after an oral glucose load

    1 study day for each administration

Secondary Outcomes (5)

  • Hormones that influence substrate and energy metabolism

    1 study day for each administration

  • Inflammatory markers

    1 study day for each administration

  • Plasma SCFA content

    1 study day for each administration

  • Circulating metabolites

    1 study day for each administration

  • Appetite VAS scoring

    1 study day for each administration

Study Arms (2)

sigmoidoscopy

EXPERIMENTAL

2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the proximal colon (sigmoidoscopy)

Other: acetate or placebo infusion

colonoscopy

EXPERIMENTAL

2 actetate concentrations and 1 placebo are administered in randomized order after clipping a catheter in the distal colon (colonoscopy)

Other: acetate or placebo infusion

Interventions

acetate or placebo infusionOTHER
colonoscopysigmoidoscopy

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Overweight, obese men

You may not qualify if:

  • athletes
  • diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Maastricht University

Maastricht, Limburg, 6200 MD, Netherlands

Location

Maastricht University

Maastricht, 6200, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Obesity

Interventions

Acetates

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Ellen Blaak, Prof.

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

April 8, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

September 15, 2015

Record last verified: 2013-08

Locations

NL(2)