N/A
N=35
Resolution of Type 2 Diabetes Mellitus: Intensive vs. Conventional Glycaemic Control After Obesity Surgery
Type 2 Diabetes Mellitus · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01257087 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6% — 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Insulin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Type 2 Diabetes Mellitus Who Achieve Fasting Blood Glucose of Less Than 5.6 mmol/l and/or HbA1c of Less Than 6% |
4; 4 | — |
| SECONDARY Percentage of Type 2 Diabetes Mellitus Patients With a Reduction in the Doses/Number of Diabetes Medications Used Preoperatively |
18; 17 | — |
| SECONDARY Number of Participants With Microvascular Events |
0; 0 | — |
Summary
Obesity surgery is very effective in improving or even curing Type 2 Diabetes in patients with obesity. Many patients stop or reduce their medication after surgery and this can happen fairly quickly. The investigators do not know whether strict control of blood glucose/sugar after the operation makes any difference in the long term. Additionally many patients prefer their blood sugars to be a "bit high" because they are afraid of hypos.A number of studies have described patients whose eye, nerve and kidney disease has deteriorated when high sugars are controlled very quickly. The investigators want to ensure that surgery provides maximum benefit and remains safe in patients with diabetes. This study will help us decide if the investigators should be strict with blood glucose after obesity surgery operations or not and whether obesity surgery is safe for the eye, nerve and kidney complications of diabetes.
Eligibility Criteria
Inclusion Criteria
- Patients with Type 2 Diabetes Mellitus who have been approved for obesity surgery
Exclusion Criteria
- Patients with Type 2 Diabetes Mellitus who do not require insulin immediately after obesity surgery
Data sourced from ClinicalTrials.gov (NCT01257087). 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.