Treatment of Hypoglycemia Following Gastric Bypass Surgery

Sponsor
Zealand University Hospital
Study ID
NCT02527993
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
25 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Glucobay (acarbose) — DRUG
    Se arm description
  • Januvia (sitagliptin) — DRUG
    Se arm description
  • Verapamil HEXAL (verapamil) — DRUG
    Se arm description
  • Victoza (liraglutide) — DRUG
    Se arm description
  • Signifor (pasireotide) — DRUG
    Se arm description
  • Continuous glucose monitoring (CGM) — DEVICE
    Continuous glucose monitoring will be performed during 6 days of the treatment period.
  • Meal tolerance test (MTT) — DIETARY_SUPPLEMENT
    A meal tolerance test will be performed at the end of the treatment period. The subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.

Study Details

Obesity is increasing worldwide and consequently the need for efficient treatment opportunities. Roux-en-Y gastric bypass (RYGB) is one of the most commonly performed bariatric procedures used in the treatment of severe obesity. The surgery results in significant and sustained weight loss and has a beneficial effect on blood glucose regulation. However, some patients experience the syndrome postprandial hyperinsulinemic hypoglycemia years after the operation, with symptoms varying from mild dizziness to confusion, loss of consciousness and seizures. Larger insulin and glucagon-like peptide 1 (GLP-1) responses to an oral glucose load are believed to play a role in the syndrome, which is not yet fully understood. There are no current treatment guidelines beside dietary recommendations. The purpose of this study is to compare different pharmacological treatments on daily blood glucose variations as well as postprandial hormonal and autonomous changes in subjects with symptoms of postprandial hyperinsulinemic hypoglycemia after RYGB.

Key Dates

Start date
Oct 31, 2015
Status verified
Mar 2018
Primary completion
Apr 8, 2017
Completion
Apr 8, 2017

Study Design

Enrollment
11 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Glucobay
    Tablet Glucobay (acarbose) 50 mg x 6 daily for 7 days.
  • Experimental: Januvia
    Tablet Januvia (sitagliptin) 100 mg orally O.D for 7 days.
  • Experimental: Verapamil
    Tablet Verapamil 120 mg orally O.D for 7 days.
  • Experimental: Victoza
    Subcutaneous injection of Victoza (liraglutide) 0,6-1,2 mg O.D for three weeks.
  • Experimental: Signifor
    Subcutaneous injection of Signifor (pasireotide) 300 µg as a single dose prior to a meal tolerance test.

Primary Outcome Measure

Changes in blood glucose (mmol/L) assessed by continuous glucose monitoring (CGM). [ Time Frame: 6 days CGM will be performed at week 1, 3, 5, 7 and 11. ]

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