Lowering Impaired Fasting Glucose Levels With Exercise

NCT03019510 | Completed

• 1 other identifier: 1202202 LIFE
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Morning hyperglycemia plays a role in the future development of insulin resistance and type 2 diabetes (T2D) (8) and is associated with numerous microvascular and cardiovascular complications and renal disease. These augmented morning glucose levels are due to an elevated endogenous glucose production (EGP), as a result of a loss of coordination between glucose levels and insulin secretion, and possibly hyperglucagonemia during the overnight period. Exercise stimulates glucose uptake and increases insulin sensitivity acutely, and may be the best lifestyle intervention to minimize the nocturnal rise in glucose levels. Prescription of the timing of exercise relative to a meal and/or to the overnight period may be particularly critical for individuals that have impaired fasting glucose (IFG) levels. Surprisingly little is known about the overnight period when elevated EGP and the synchrony between glucose and c-peptide/glucagon levels becomes disturbed. This novel study will provide insight into the hormonal/metabolic milieu of a dinner meal, the evening and overnight period that occurs in non-obese, OB and OB+IFG individuals; it will also establish if the timing of exercise can attenuate nocturnal glucose elevations, and if this is associated with improved hormonal synchrony. This project will compare EGP, β-cell function and hormonal responses between morning and evening exercise on the postprandial and overnight period in obese individuals with/without IFG levels. Fifty-four subjects will be studied during the evening meal (EGP and β-cell function), postprandially and through the overnight period (1600-0700 h), allowing us to examine some of the potential mechanisms for the elevation in overnight glucose levels. This is the first study that will examine this issue from pre-dinner through the night while previous studies have only examined chronically fasted individuals and this study will lay the groundwork for understanding the pathology of the predawn phenomena in OB+IFG individuals. These potentially translational findings may impact the efficiency of physician communication to patients concerning exercise. These investigators are one of the few groups that study subjects through the overnight period and have the facilities and capability to do this research.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• fasting glucose level

  the hour prior to study completion will be used for this measurement

  avg of every 15 min for 1 hr will be compared between interventions

Secondary Outcomes (4)

• endogenous glucose production

  the endogenous glucose production for 4 hr will be compared between intervention

• insulin concentrations

  the insulin concentrations 13 hr will be compared between interventions

• glucagon concentrations

  the glucagon concentrations for 13 hr will be compared between interventions

• beta cell function

  beta cell function determined for 4 hr postprandial

Study Arms (3)

no exercise

PLACEBO COMPARATOR

Subjects will be studied from 6 pm to 7 am following 48 hr of no exercise

Behavioral: No exercise; Behavioral: Morning exercise; Behavioral: Evening exercise

morning exercise

ACTIVE COMPARATOR

Subjects will be studied from 6 pm to 7 am. Subjects will have exercised at 7 am on that day.

Behavioral: No exercise; Behavioral: Morning exercise; Behavioral: Evening exercise

evening exercise

ACTIVE COMPARATOR

Subjects will be studied from 6 pm to 7 am. Subjects will exercise at 8 pm following dinner on the study day.

Behavioral: No exercise; Behavioral: Morning exercise; Behavioral: Evening exercise

Interventions

No exercise BEHAVIORAL

No exercise will be done on the day of the study night to be tested

evening exercise; morning exercise; no exercise

Morning exercise BEHAVIORAL

Early morning exercise will be done on the day of the study night to be tested

evening exercise; morning exercise; no exercise

Evening exercise BEHAVIORAL

Evening exercise will be done on the day of the study night to be tested

evening exercise; morning exercise; no exercise

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• yrs of age body mass index (BMI): 30-45 kg/m2 for the obese subjects \<24.5 kg/m2 for the non-obese subjects weight stable during prior 6 months non-smokers OB with impaired fasting glucose: elevated elevated morning fasting glucose levels \>110 mg/dL for 5 of 7 days non-obese and OB subjects: fasting glucose levels \< 100 mg/dL - 2hr OGTT glucose value \<140 mg/dL

You may not qualify if:

• Significant hypertension BP \> 180 systolic or \> 100 diastolic, at rest. Untreated hypothyroidism or hyperthyroidism (will be included if treated and euthyroid) Active users of tobacco and chronic alcohol abuse. Renal, hepatic, pulmonary, adrenal, or pituitary disease. Liver function tests with \> 2xULN.

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

Study Officials

• Jill Kanaley, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 12, 2017
• Study Start: October 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: September 30, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)