Glucose Challenge for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity+6 More
Glucose Challenge - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study how well natriuretic peptides (hormones produced by the heart) work in people with a genetic variation that causes lower levels of these peptides.

Eligible Conditions
  • Obesity
  • Metabolic Syndrome X
  • Cardiovascular Diseases
  • Exercise
  • Energy Expenditure
  • Natriuretic Peptides
  • Glucose Metabolism

Treatment Effectiveness

Study Objectives

4 Primary · 23 Secondary · Reporting Duration: About 3 hours on the exercise challenge visit day after consuming study meals for 4 days

Day 4
Change in Exercise Energy Expenditure between the high genotype and low genotype group.
Change in Resting Energy Expenditure (REE) between the two genotype groups.
Change in miR-425 levels following a standardized exercise challenge in those with low ANP genotype.
Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following exercise challenge between the two genotype groups.
Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following exercise challenge.
Change in miR-425 levels with change in serum glucose levels following exercise challenge between the two genotype groups.
Change in miR-425 levels with change in serum glucose levels following exercise challenge.
Change in miR-425 levels with change in serum insulin levels following exercise challenge between the two genotype groups.
Body Weight Changes
Change in the NPs (ANP, BNP, NTproBNP) with standardized exercise protocol between the two genotype groups.
Change in the free fatty acid levels with standardized exercise protocol between the two genotype groups.
Change in the glycerol levels with standardized exercise protocol between the two genotype groups.
Body Weight Changes
Change in the serum insulin levels with standardized exercise protocol between the two genotype groups.
Correlation of resting miR-425 levels with REE
Correlation of resting miR-425 levels with REE between the genotype groups.
Day 5
Change in MRproANP levels following a standardized oral glucose challenge between the high genotype group and low genotype group.
Change in miR-425 levels following a standardized oral glucose challenge in those with low ANP genotype.
Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following glucose challenge between the two genotype groups.
Change in miR-425 levels with change in NP levels (ANP, MRproANP, BNP, and NTproBNP) following glucose challenge.
Change in miR-425 levels with change in serum glucose levels following glucose challenge between the two genotype groups.
Change in miR-425 levels with change in serum glucose levels following glucose challenge.
Change in miR-425 levels with change in serum insulin levels following glucose challenge between the two genotype groups.
Change in miR-425 levels with change in serum insulin levels following glucose challenge.
Change in the NPs (ANP, BNP, NTproBNP) following the glucose challenge between the high genotype group and low genotype group.
Change in the serum glucose following the glucose challenge between the high genotype group and low genotype group.
Change in the serum insulin following the glucose challenge between the high genotype group and low genotype group.

Trial Safety

Trial Design

2 Treatment Groups

Active Comparator: High NP Genotype Group
1 of 2
Experimental: Low NP Genotype Group
1 of 2
Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Glucose Challenge · No Placebo Group · N/A

Active Comparator: High NP Genotype GroupExperimental Group · 4 Interventions: Exercise capacity VO2 max determination, Exercise Challenge, Glucose Challenge, Study diet · Intervention Types: Other, Other, Other, DietarySupplement
Experimental: Low NP Genotype GroupExperimental Group · 4 Interventions: Exercise capacity VO2 max determination, Exercise Challenge, Glucose Challenge, Study diet · Intervention Types: Other, Other, Other, DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Study diet
2017
N/A
~90

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: about 3 hours on the exercise challenge visit day after consuming study meals for 4 days

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,419 Previous Clinical Trials
2,217,465 Total Patients Enrolled
65 Trials studying Obesity
458,614 Patients Enrolled for Obesity
Pankaj Arora, MD, FAHAPrincipal InvestigatorUniversity of Alabama at Birmingham
3 Previous Clinical Trials
860 Total Patients Enrolled
2 Trials studying Obesity
660 Patients Enrolled for Obesity

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Age more than or equal to 18
No history of congestive heart failure, heart attack, or stroke
You do not take insulin

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 3rd, 2021

Last Reviewed: October 2nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Alabama100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Alabama at Birmingham100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. University of Alabama at Birmingham: < 24 hours
Typically responds via
Email100.0%
References