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The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers (Sleep GLP-1)

M

Mahidol University

Status

Completed

Conditions

Prediabetes

Treatments

Other: Oral glucose tolerance

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02229487
08-57-16

Details and patient eligibility

About

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

Enrollment

51 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

51 participants in 2 patient groups

Normal Sleepers
Active Comparator group
Description:
Prediabetes patients with normal sleep duration (7-8 hours/ night) as measured objectively
Treatment:
Other: Oral glucose tolerance
Short Sleepers
Experimental group
Description:
Prediabetes patients with short sleep duration (\<6 hours/night) as measured objectively
Treatment:
Other: Oral glucose tolerance

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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