Prediabetes
Conditions
Keywords
Prediabetes, Short sleepers, GLP-1
Brief summary
Hypothesis 1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration. 2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal
Interventions
OTHEROral glucose tolerance
Sponsors
Merck Sharp & Dohme LLC
Ramathibodi Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with prediabetes (HbA1c 5.7-6.4% or history of fasting plasma glucose 100-125 mg/dl) who receive medical care at Ramathibodi Hospital 2. Age 18 or older 3. Can understand Thai (speaking, listening and reading) 4. Agree to participate by written informed consent
Exclusion criteria
1. Those who depend on others for feeding (such as stroke patients) 2. Shift workers 3. History of congestive heart failure or low ejection fraction 4. Chronic obstructive pulmonary disease, end stage renal disease or chronic liver disease (AST or ALT \> 3 times the upper limit of normal) 5. Use of medications: opioids/ narcotics , alpha blockers (prazosin, doxazosin, terazosin), clonidine, methyldopa, nitroglycerin 6. Patients with permanent pacemaker 7. History of previous stroke
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GLP-1 Levels in Response to Oral Glucose Tolerance Test | 2 weeks | Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Sleeper Sleep duration as measured by actigraphy \>=6.5 h/night | 24 |
| Short Sleeper Sleep duration as measured by actigraphy =\<5.75 h/night | 27 |
| Total | 51 |
Baseline characteristics
| Characteristic | Normal Sleeper | Short Sleeper | Total |
|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 9.8 | 55.8 years STANDARD_DEVIATION 6.7 | 55.7 years STANDARD_DEVIATION 8.2 |
| BMI | 26.7 kg/m^2 STANDARD_DEVIATION 3.2 | 26.8 kg/m^2 STANDARD_DEVIATION 3.8 | 26.8 kg/m^2 STANDARD_DEVIATION 3.5 |
| Race/Ethnicity, Customized Thai | 24 Participants | 27 Participants | 51 Participants |
| Region of Enrollment Thailand | 24 Participants | 27 Participants | 51 Participants |
| Sex: Female, Male Female | 19 Participants | 20 Participants | 39 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 0 / 24 | 0 / 27 |
| serious Total, serious adverse events | 0 / 24 | 0 / 27 |
Outcome results
Primary
GLP-1 Levels in Response to Oral Glucose Tolerance Test
Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Short Sleepers | GLP-1 Levels in Response to Oral Glucose Tolerance Test | 16.66 pmol/l.h |
| Normal Sleepers | GLP-1 Levels in Response to Oral Glucose Tolerance Test | 18.57 pmol/l.h |
p-value: 0.209Wilcoxon (Mann-Whitney)