N/A
N=17
Insulin Secretion in Diabetes Before and After Glycemic Control
Diabetes · Hyperglycemia
Bottom Line
View on ClinicalTrials.gov: NCT00469833 ↗Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia. — 0.67; 0.75; 1.11; 0.76 pmol/min
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- insulin glargine (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia. |
0.67; 0.75; 1.11; 0.76 | — |
| PRIMARY C-peptide Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia. |
7.10; 5.63; 10.89; 6.02 | — |
| PRIMARY Insulin Concentration in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia. |
546.9; 316.4; 934.6; 395.6 | — |
| SECONDARY HbA1c Before and After 2 Months of Insulin Treatment to Improve Average Glycemia. |
8.6; 7.1 | — |
Summary
The objective of this project is to understand defects in insulin secretion that contribute to abnormal glucose metabolism in patients with diabetes. In particular the effects of signals released from the intestine to stimulate insulin secretion will be tested. Patients with type 2 diabetes will have insulin secretion in response to glucose and intestinal factors before and after insulin treatment to lower their blood glucose. It is expected that the results of this work will provide valuable information for treating diabetic people.
Eligibility Criteria
Inclusion Criteria
- Aim 1:
- (non-diabetics)
- male/female 30-65 yrs old,
- free of active medical disease,
- no history of diabetes.
- (diabetics)
- HbA1c=6.5-8.5,
- treated with metformin, a sulfonylurea, or combination,
- Stable body wt with BMI 28-40.
- Aim 2: Same as above
- Aim 3: Diabetic with HgA1c 8.0-9.5
Exclusion Criteria
- Aim 1: For both groups: no history of: pancreatitis, cardiac, gastrointestinal, renal or liver disease.
- Aim 2: Same as above
- Aim 3: Same as above, plus a diagnosis of incipient diabetic nephropathy severe nonproliferative, or proliferative retinopathy.
Data sourced from ClinicalTrials.gov (NCT00469833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.