- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03019510
Lowering Impaired Fasting Glucose Levels With Exercise (LIFE)
Dawn Phenomena: Lowering Impaired Fasting Glucose Levels With Exercise (LIFE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In individuals with type 2 diabetes (T2D), chronically elevated glucose and insulin levels result in numerous health complications. Maintaining tight glucose control is difficult for individuals with T2D, particularly in the postprandial period and in the morning period just prior to waking. In the postprandial period, the combined effect of insulin resistance and beta cell dysfunction results in a prolonged elevation in glucose levels, and augmented insulin levels in an attempt to reduce the circulating glucose levels. In the overnight period, there is evidence of enhanced endogenous glucose production and of a disruption of the interaction between glucose levels and insulin secretion. Early work in individuals with T2D demonstrated that with continued fasting, glucose levels stopped declining in the evening and subsequently rose throughout the night to reach a morning maximum, and this elevation persisted till noon. Additionally these authors demonstrated that insulin levels and insulin secretion rates did not parallel the nocturnal glucose changes in individuals with T2D, while in the controls the nocturnal glucose and insulin secretion rates coincided. Evidence is also emerging that hyperglucagonemia may be occurring in the setting of deficient insulin secretion, and may be playing a role in the elevated postprandial glucose levels and in the overnight period. These studies provide preliminary evidence that there is disruption in the fine coordination between glucose levels and glucagon and insulin secretion, and that this is exacerbated more in the overnight period than during the waking hours. Previous studies examining the overnight period have been conducted following prolonged fasting (~24-34 h), however, most people do not fast for extended periods of time prior to going to bed. Additionally, individuals with T2D often know that meal composition the evening prior can exacerbate the elevated fasting glucose levels the following morning, thus highlighting the need to examine the effect of meal composition on overnight glucose control. To date, very little is known about the pathology of why fasting glucose levels are elevated in many obese individuals. There appears to be asynchrony between glucose and insulin levels in the overnight period but very little research has focused on this phenomenon or how meal composition affects overnight glucose levels. This study will provide evidence of potential mechanisms for the elevation in overnight glucose levels and the findings will be translatable for individuals with impaired fasting glucose (IFG) levels to understand the importance of meal composition in the evening period.
The specific aims of this project are:
- To examine the hormonal responses (glucagon, c-peptide, insulin, incretins) in response to a meal in the postprandial period and the synchronization between glucose and insulin/glucagon during the overnight period in non-obese individuals and obese individuals with impaired fasting glucose levels (IFG).
- To determine if the meal composition (standard meal: 55% carbohydrate, 20% protein, 25% fat vs. high fat/fructose: 40% carbohydrate- 25% fructose, 40% fat, 20% protein) will alter the hormonal responses (glucagon, insulin, incretin) in the postprandial period, and if this change in meal composition will impact glucagon levels and glucose/c-peptide synchrony in the overnight period.
Experimental design: Subjects will participate three times; 1) no exercise, 2) 2 hr post dinner exercise, and 3) morning exercise (~7am). The order in which subjects undergo each treatment will be randomized prior to study enrollment. Eligible subjects will initially undergo baseline testing for assessment of body composition, exercise stress test and blood screening. All subjects will have impaired fasting glucose levels. All subjects will undergo 3 study days that will start at ~1600 h and continue until 0700 h the following morning. They will receive a standard meal (55% carbohydrate, 20% protein, 25% fat) at 1800 h and blood samples will be taken from ~4:30 pm until 7 am.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Missouri
-
Columbia, Missouri, United States, 65211
- University of Missouri
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
25-65 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
Exclusion criteria overt cardiovascular disease sleep apnea surgical history for weight loss use of weight-loss medications or active dieting participate in exercise > 3 days/wk per week at a moderate or vigorous intensity pregnant or lactating women. Medications for glycemic control (including insulin), β-blockers, glucocorticoids, testosterone, or other medications for chronic pulmonary, cardiac or other systemic diseases.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: no exercise
Subjects will be studied from 6 pm to 7 am following 48 hr of no exercise
|
No exercise will be done on the day of the study night to be tested
Early morning exercise will be done on the day of the study night to be tested
Evening exercise will be done on the day of the study night to be tested
|
Active Comparator: morning exercise
Subjects will be studied from 6 pm to 7 am.
Subjects will have exercised at 7 am on that day.
|
No exercise will be done on the day of the study night to be tested
Early morning exercise will be done on the day of the study night to be tested
Evening exercise will be done on the day of the study night to be tested
|
Active Comparator: evening exercise
Subjects will be studied from 6 pm to 7 am.
Subjects will exercise at 8 pm following dinner on the study day.
|
No exercise will be done on the day of the study night to be tested
Early morning exercise will be done on the day of the study night to be tested
Evening exercise will be done on the day of the study night to be tested
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fasting glucose level
Time Frame: avg of every 15 min for 1 hr will be compared between interventions
|
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 Outcome Measures
Outcome Measure |
Time Frame |
---|---|
endogenous glucose production
Time Frame: the endogenous glucose production for 4 hr will be compared between intervention
|
the endogenous glucose production for 4 hr will be compared between intervention
|
insulin concentrations
Time Frame: the insulin concentrations 13 hr will be compared between interventions
|
the insulin concentrations 13 hr will be compared between interventions
|
glucagon concentrations
Time Frame: the glucagon concentrations for 13 hr will be compared between interventions
|
the glucagon concentrations for 13 hr will be compared between interventions
|
beta cell function
Time Frame: beta cell function determined for 4 hr postprandial
|
beta cell function determined for 4 hr postprandial
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1202202 LIFE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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