Incretin Effect in People With Impaired Fasting Glucose

Exploring the Incretin Effect in People With IFG

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00795275

Acronym

1651

Enrollment

Registered

2008-11-21

Start date

2008-01-31

Completion date

2008-11-30

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

pre-diabetes, isotopes, insulin secretion, insulin action, GLP-1, simple obesity, impaired fasting glucose

Brief summary

Regulation of endogenous glucose production (EGP) and insulin secretion are major actions of glucagon-like peptide-1 (GLP-1). Determining whether alterations in GLP-1 may contribute to abnormal EGP and insulin secretion in people with impaired fasting glucose (IFG) was the objective of the current study. The investigators hypothesized that defects in GLP-1 may explain the inappropriate basal EGP and diminished insulin secretion in IFG, and, furthermore, that by increasing circulating GLP-1 levels (using a new medicine called sitagliptin) the investigators could reverse these defects.

Interventions

DRUGSitagliptin Phosphate

Januvia 100 mg po qd x 28 days for all subjects after baseline measures made

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

45 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy, sedentary, non-smokers, men and women 45-70 years old Subjects were placed into 1 of the 2 groups based on two 2-hour 75g oral glucose tolerance tests (2h OGTT), separated by one week: a control group with normal glucose tolerance (NGT; n=14; fasting glucose \<5.6 mmol/l and 2h OGTT \<7.8 mmol/l), or IFG (n=10; fasting glucose 5.6-6.9 mmol/l, and 2h OGTT \<7.8 mmol/l).

Exclusion criteria

* Subjects were excluded for: thyroid stimulating hormone \<50 or \>500 milliunits/L, fasting triglycerides \>10.3 mmol/l, creatinine \>130 μmol/l, elevated liver function tests (\>2 times normal), hematocrit \< 38%, or white blood cell count \<3.0 x 103. Use of medications for lipid and/or glucose lowering also excluded enrollees. Women may not have used hormone replacement therapy in the past 1 year. Smokers. BMI \<25 or \>40 kg/m2. Diabetes or impaired glucose tolerance.

Design outcomes

Primary

Measure	Time frame
Change in Endogenous Glucose Production	Baseline and 28 days
Change in Insulin Secretion	Baseline and 28 days

Secondary

Measure	Time frame
Baseline and Change in Hormones, Substrates and Insulin Action: Glucagon	Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: GLP-1	Baseline and 28 days
Insulin Secretion in Response to Oral vs. IV Glucose	Baseline
Baseline and Change in Hormones, Substrates and Insulin Action: FFA	Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: Glycerol	Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: Lactate	Baseline and 28 days
Baseline and Change in Hormones, Substrates and Insulin Action: C-peptide	Baseline and 28 days

Countries

United States

Participant flow

Participants by arm

Arm	Count
People With Impaired Fasting Glucose people with impaired fasting glucose Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	11
People With Normal Glucose Tolerance people with normal glucose tolerance Januvia (sitagliptin phosphate) : Januvia 100 mg po qd x 28 days for all subjects after baseline measures made	15
Total	26

Baseline characteristics

Characteristic	People With Normal Glucose Tolerance	People With Impaired Fasting Glucose	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	15 Participants	11 Participants	26 Participants
Age, Continuous	58 years STANDARD_DEVIATION 1.6	59 years STANDARD_DEVIATION 2.3	59 years STANDARD_DEVIATION 2
Region of Enrollment United States	15 participants	11 participants	26 participants
Sex: Female, Male Female	7 Participants	5 Participants	12 Participants
Sex: Female, Male Male	8 Participants	6 Participants	14 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 11	0 / 15
serious Total, serious adverse events	0 / 11	0 / 15